Quality Assurance Auditor Resume Samples
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Quality Assurance Auditor Resume Samples
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LH
L Hickle
Letitia
Hickle
85649 Blick Port
Philadelphia
PA
+1 (555) 943 8651
85649 Blick Port
Philadelphia
PA
Phone
p
+1 (555) 943 8651
Experience
Experience
Los Angeles, CA
Quality Assurance Auditor
Los Angeles, CA
Pfannerstill, Schultz and Stark
Los Angeles, CA
Quality Assurance Auditor
- Record/track quality assessment scores and provide feedback to reduce errors and improve processes and performance to ensure the quality of the network
- Works with Quality Assurance Manager on development of new testing
- Monitors performance and supports efforts to develop and implement changes to improve the production process
- Meet established time frames and rates of performance for the quality and quantity of work for the position
- Working within Quality leadership, establish a highly effective Internal Audit and Corrective and Prevention Action (CAPA) program
- Identify defects and improve departmental performance by supporting quality, operational efficiency and production goals
- Assist with document control development related to quality systems
Boston, MA
Senior Quality Assurance Auditor
Boston, MA
Wisozk Inc
Boston, MA
Senior Quality Assurance Auditor
- Assist in developing and providing basic and advanced regulatory training to QA and operations personnel
- Review protocols and batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures
- Assist in scheduling and tracking QA audits, inspections and procedures as requested
- Writes, reviews or revises QA Standard Operating Procedures (SOPs) / Work Instructions (WIs)
- Provides training on quality/regulatory area to Operations departments
- Conduct quality assurance consultancy activities and projects for clients within budget and established timelines
- Assist in training of new Quality Assurance staff
present
New York, NY
Senior Claims Quality Assurance Auditor
New York, NY
DuBuque, Predovic and Borer
present
New York, NY
Senior Claims Quality Assurance Auditor
present
- Assists development and maintenance of documents and tools to complement quality programs on all domestic operations
- Assists Regional Managers with self-audit and inspection processes
- Assists in formulating and coordinating branch level quality processes
- Participates in special projects or performs duties in other areas as requested
- Supports the service delivery, internal & external complaint resolution, sales, product development and client retention processes
- Trains managers, supervisors, and staff in quality programs and corrective actions
- Interacts with clients in matters of quality analysis
Education
Education
Bachelor’s Degree in Chemistry
Bachelor’s Degree in Chemistry
Colorado State University
Bachelor’s Degree in Chemistry
Skills
Skills
- Knowledge of quality assurance processes and procedures, specifically as they relate to GLP. GMP knowledge also acceptable
- Basic computer skills and ability to learn and become proficient with appropriate software
- Considerable knowledge of GXP regulations and quality assurance auditing techniques
- Excellent oral and written communication skills (including appropriate use of medical and scientific terminology) along with good interpersonal skills
- Comprehensive knowledge of products, regulatory standards (e.g. FDCPA, UDAAP, FCRA, SCRA), policies and procedures applicable to assigned area
- Strong attention to detail
- Superb knowledge of Laboratory Quality Systems
- Strong knowledge of process design and controls
- Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelineshorough working knowledge of SOPs and WPDs)
- Effective and professional communication ability, written and verbal
15 Quality Assurance Auditor resume templates
Read our complete resume writing guides
1
Quality Assurance Auditor Resume Examples & Samples
- Evaluation of incoming components, finished goods and other materials meet established specifications
- Assist in Supplier Certification and Component monitoring programs
- Create Quality Notifications (QNs) and monitor responses in SAP
- Establish finished goods production standards for online production runs
- Release finished goods from quarantine and perform audits as needed
- Provide support for Operations personnel in Production and Filling departments
- 1-3 Years of related experience
- Good oral and written communication skills (spelling, gramar)
- Attention to detail and math aptitude is necessary. Must be comfortable with the use of decimals and fractions
- Experience with the use of measuring devices (rulers, digital calipers, scales, thickness gauges, etc.)
- Must have the ability to work independently and must be computer literate
- Ability to differentiate colors and shades
2
Quality Assurance Auditor Resume Examples & Samples
- 5+ years of related experience in Pharmaceutical industry
- Bachelor's Degree in a Science related field
- Familiarity with manufacturing, packaging, testing, and quality systems
- Proficiency in MS Word, Excel, PowerPoint, Vision, and Access
- Ability to utilize software and customized programs to meet business needs
- Able to multitask efficiently and effectively
- 2+ years of Audit experience in Pharmaceutical industry
- American Society for Quality (ASQ) Certified Quality Auditor (CQA) Certification or equivalent
- Good organization, planning and time management skills
3
Quality Assurance Auditor Resume Examples & Samples
- The Quality Assurance Auditor is responsible for performing quality assurance activities as directed by the Quality Assurance Supervisor and/or the Quality Assurance Manager on life science industry accounts
- He/she works with the Quality Assurance Supervisor and/or Manager and account team members to assure services are delivered in a compliant, efficient, and consistent manner to meet client needs
- The Quality Assurance Auditor will conduct quality assurance reviews of project deliverables and operations from transition through steady state operations, evaluating compliance with the Life Science Industry Quality Management System
- Degree (Bachelor or Master) in life-science (or equivalent)
- A minimum of 2 years experience in the life science industry (pharmaceutical, biotechnology, medical device firm, contract research organization)
- Basic knowledge regarding the components of a quality management system in a life science firm
- Basic knowledge of regulatory requirements for infrastructure qualification and/or software validation projects within the life science industry
- Practical experience with audits and quality agreements
- Analytical thinking and problem-solving attitude
- Able to work with a high degree of autonomy and self-management, being able to proactively find solution to problems and knowing when to escalate
- Good negotiation skills; result oriented
- Additional European language
4
Quality Assurance Auditor Resume Examples & Samples
- Three years’ experience in quality assurance/control methodology and safety programs, including establishing programs from inception through successful implementation
- Three years’ experience in design, implementation and assessment of internal program performance controls
- 2 years' experience in occupational safety practice and proof of 30-hour OSHA training, MSHA training or 40-hour HAZWOPER
- Experience with implementing ISO 9001:2008 certification into a program
- Ability to speak, read, and write English
- Formal Quality Management training
- ISO 9001:2008 Internal Auditor Certification
- Formal Environmental training
- Formal 30 – hour OSHA Training
- Formal HAZMAT/HAZWASTE Handling and Storage training
- ISO 14000 Certification
- Professional certification/accreditation (STS, CSP, OHST, CHST, etc.)
5
Senior Risk Adjustment Quality Assurance Auditor Resume Examples & Samples
- Assists Senior Manager with QA and training of CDQI Quality Assurance Auditor team
- Performs quality audits on vendor coding results as well as internal Care Delivery coding teams as needed
- Ensure that Optum Coding Guidelines are consistently applied in all processes
- Provide input and valuable feedback on audit results in a timely manner
- Provide ICD10-CM coding training, as it relates to HCC coding, as requested
- Provides support and assists Care Delivery with various coding initiatives as needed
- Develops relationships with Care Delivery Organizations and communicates guidelines and requirements of Risk Adjustment Payment System to ensure correct coding and documentation
- Associates’ degree or higher- completed college coursework with significant equivalent working experience may substitute for degree
- Coding Certification required (RHIT, CCS or CPC; CPC-A or CCA designation is not acceptable)
- 7+ years experience ICD-9 / 10 coding, preferably in a Managed Care setting, with strong attention to detail and high accuracy rate
- 5+ years coding experience in a provider’s office, inpatient setting or a Medicare Advantage health plan setting - can be combined experience
- 4+ years experience working with CMS Risk Adjustment guidelines
- 4+ years in a coding auditor function
- 4+ years provider education experience - communicating directly with providers
- 3+ years compliant physician query experience
- Proficient knowledge and understanding of CMS-HCC model and guidelines
- Proficient Knowledge of HEDIS / STARS
- Previous experience working with Optum Coding guidelines
- Strong knowledge of ICD-10-CM guidelines
- Ability to work a flexible schedule to accommodate meetings in various time zones as needed
- Self-motivated; ability to work with minimal supervision
- Microsoft Office proficiency (Word, Excel, PowerPoint & Outlook)
- Up to 15% travel (local, non-local meetings)
- Must be able to continuously meet the requirements for a telecommuter, i.e. live in a location that can receive a UnitedHealth Group approved high speed internet connection, have a secure designated office space to maintain PHI, meet or exceed all performance expectations
- 2+ years supervisory experience
- 1+ years HEDIS / STARS experience
6
Senior Quality Assurance Auditor Resume Examples & Samples
- Schedules, conducts, and documents assigned audits of the Company’s projects and operational processes in accordance with approved procedures, schedules, and formats. Specific audit areas will include, but are not limited to
- Provides consultancy on quality and regulatory related issues for QA functions
- Provides training on quality/regulatory area to Operations departments
- Writes, reviews or revises QA Standard Operating Procedures (SOPs) / Work Instructions (WIs)
- Performs other work-related duties as assigned. Extensive travel may be required (up to 75%)
7
Risk Adjustment Quality Assurance Auditor Resume Examples & Samples
- Assist with Internal Risk Adjustment Clinical Coding Review program
- Clinical Quality Documentation assessment
- Performs quality audits on vendor charts as well as internal coding team charts as needed
- Identifies issues and trends in coding and documentation that affect provider risk adjustment factor scores
- Provides input and valuable feedback on audit results
- Develops relationships with Care Delivery and communicates guidelines and requirements of Risk Adjustment Payment System to ensure correct coding and documentation
- Cross-functional collaboration with multiple teams and functions
- Associates’ degree or higher or significant equivalent work experience
- Coding Certification required (CPC, CCS, CCS-P, or RHIT; CPC-A or CCA designation is not acceptable)
- 4+ years’ experience ICD-9/10 coding, preferably in a Managed Care setting, with strong attention to detail and high accuracy rate
- 2+ years’ Medicare Risk Adjustment/HCC Coding experience
- 2+ years’ Provider education experience
- Compliant Physician query experience / knowledge
- 1+ year experience in a coding auditor role
- Proficient knowledge of CMS-HCC model and guidelines
- ICD-10-CM proficient
- Knowledge of HEDIS/STARS
- Normal schedule M-F 8am-5pm, ability to work a flexible schedule to meet business needs and accommodate meetings in various time zones as needed
- Ability to work across a matrix environment
- CRC (Certified Risk Coder) in addition to required coding certification
- ICD-10-CM trainer
- 1+ years HEDIS/STARS experience
- Previous experience with WebEx or similar virtual meeting tools
- Previous experience with data analysis and reporting
- Previous experience using diagnosis coding data and trends to identify training opportunities
8
Senior Quality Assurance Auditor Resume Examples & Samples
- Bachelor’s degree in relevanet field and 5 years of relevent experience; or
- HS/GED and 8 years of relevant regulatory auditing experience
- Take and pass the RQAP GLP Examination
- Basic familiarity with Microsoft Office Suite
9
Bioresearch Quality Assurance Auditor Resume Examples & Samples
- A minimum of a bachelor’s degree (or equivalent) is required
- A minimum of 8 of experience working in an R&D environment is required
- Experience in the Computerized System Validation (CSV) is required
- Auditing experience in CSV space is preferred
- Expertise in additional compliance disciplines (e.g. GCP, GLP, PV), is preferred
- Experience in mentoring staff is preferred
- Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is preferred
- Knowledge of procedural and records management requirements in a regulated industry is preferred
- Prior experience in a regulated medical industry (Pharmaceutical, Medical Devices, Consumer, CRO and/or Biotech) is required
- Prior pharmaceutical and quality/compliance related experience is preferred
- This position will be based in Raritan, NJ, Titusville, NJ, or Spring House, PA and may require up to 50% overnight domestic and possibly international travel.Quality Assurance
10
Quality Assurance Auditor Resume Examples & Samples
- Inspect incoming materials to assure conformance with specifications
- Audit permanent production processes (Vacuum Form Operation, Assembly of Permanent Displays, etc.) ensuring compliance with work order specifications, and that finished product meets customer requirements
- Verify compliance with cGMPs (Good Manufacturing Practices) and SOPs (Standard Operating Procedures)
- Inspect prototypes and/or First Articles
- Accurately use measuring and testing equipment (ruler, calipers, etc.)
- Communicate issues to operations and vendors, if necessary
- Record data; generate spreadsheets and reports as needed
- Communicate with Project Managers, Engineers, Model Shop, and Customers, if necessary
- Communicate Company policies, procedures, and customer requirements to other WRMD employees and to participate/assist in their development as needed
- Participate in and/or assist with internal QA audits, Customer audits, and Regulatory Agency audits as required
- Assist with and/or conduct cGMP training, if requested
- Assist Assembly QA as needed
- May require occasional travel
- Responsible for the overall Safety and cleanliness of equipment and area
- Work in a safe and efficient manner in accordance with company policies and procedures
11
Quality Assurance Auditor Resume Examples & Samples
- Attends weekly meetings to represent Quality Assurance for production of products at CMOs
- Reviews batch records, carton label proofs, solution records, and participates in resolution of deviations
- Reviews and approves validation protocols, reviews and approves shipping validation
- Experience with quality records such as deviations, change controls, CAPAs, and laboratory investigation failures
- Guides others in resolving complex issues in specialized area based on existing solutions and procedures
- Serves as an expert within own discipline
- Serves as a resource for best practices/quality on functional teams or project
- Requires specialized depth and/or breadth of expertise
- Solves complex problems; takes a broad perspective to identify solutions
- Works independently, with guidance in only the most complex situations
- Progression to this level is typically restricted on the basis of business requirement
12
Quality Assurance Auditor Resume Examples & Samples
- Audits laboratory data for compliance with methods and standard operating procedures and report findings
- Assists in the preparation of audit findings and/or other related information
- Previous QA or lab experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience
- Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelineshorough working knowledge of SOPs and WPDs)
- Good problem solving abilities
- Proven flexibility and adaptability
13
Quality Assurance Auditor Resume Examples & Samples
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years)
- Demonstrated proficiency and led a range of project based or internal GMP audits and vendor audits to high standards required by management
- Above average negotiation and conflict management skills
14
Quality Assurance Auditor Resume Examples & Samples
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification(Bachelors degree or equivalent; relevant formal academic or vocational training; Associates degree and relevant experience in lieu of Bachelor's degree)
- Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2+ years’) or equivalent combination of education, training, & experience
- Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory
- Agency guidelines)
- Thorough working knowledge of SOPs and WPDs
- Excellent oral and written communication skills (including appropriate use of medical and scientific
- Terminology)
15
Quality Assurance Auditor Resume Examples & Samples
- Auditor I: Previous QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 1-2 years’) or equivalent combination of education, training, & experience
- Auditor II: Previous QA experience that provides the knowledge, skills, and abilities to perform the job(comparable to 2-5 or more years’) or equivalent combination of education, training, & experience
- Meets competencies for Associate QA (or Auditor I for Auditor II position) plus
16
Quality Assurance Auditor Principal Resume Examples & Samples
- Conducts audits for contract compliance, using SeeSOR Contract Management and Monitoring System and QA SOPs for Major Requirements of individual SOR line items
- Understand, facilitate and implement the QA Vendor/Supplier oversight program requirements and the FAA Part 145 Repair Station compliance in order to achieve desired results, and meet customer metrics and standards
- Performs Supplier audits and recommends approvals to Purchasing in support of Supply Chain management
- Provides quality assurance audits of all Air Wing aircraft, ground support equipment and associated aviation assets to ensure all are within the contract, SOW requirements and performance standards
- Establish policies and procedures to the QA Supplier SOP for Supplier compliance and surveillance that ensures safe operation of INL/A aircraft in order to meet fully mission capable rates established by our customer
- Assess departmental best practices and develop methods to export them company-wide,
- Conduct performance audits and assists section, department, and/or Program in developing a plan to correct identified shortcomings
- Assist in the alignment of organizational activities and processes to the goals of the organization; support the alignment of goals, initiatives, people, processes and systems within the QA department
- Set critical success factors/performance measurements to meet major requirements of individual SeeSOR SOR line items and contract requirements
- Assist with the ongoing training of Quality Assurance Auditors, Functional Departments, and other relevant personnel as necessary
- Conduct performance audits and analysis of outcomes with Functional Units; evaluate and report progress to Quality Assurance Manager
- Acts on behalf of the Quality Assurance Manager as needed during his/her absence
- Must be familiar with the ISO/AS 9100 Quality and FAA 14 CFR Part 145 regulatory requirements
- General understanding of commercial and aerospace / defense regulations and standards. Military/commercial aviation experience, QA and/or maintenance management
- Ability to write clear and precise audit reports, procedures and documents. Ability to read, write and interpret technical data and special-operating instructions is required
- Ability to understand and interpret the content of procedural and standard operational procedural manuals and instruction booklets
- Knowledge of Lean/Six Sigma or other contemporary methodologies and tools for continuous improvement
- Ability to use management software tools and be able to review and evaluate outcomes and recommend appropriate changes
- Working knowledge of Microsoft Office tools
- Fully knowledgeable of inspection and audit methods and sampling techniques
- Ability to perform trend analysis, compile results, prepare reports, present findings, recommend corrective and preventive actions
- Strong oral and written communication skills Ability to effectively communicate quality and internal audit reports to senior mgr, Vendors and FAA
- In-depth working knowledge of military, commercial and FAA technical publications are desired
- Aviation Maintenance or Flying knowledge, skills and abilities through formal military or civilian educational schools are desired
- Ability to take personal responsibility for allocated tasks and work without supervision
- Ability to meet any Government/Company licensing/qualification requirements for the position
- Ability to obtain and maintain a Moderate Risk Public Trust (MRPT) through Department of State Background Investigation is a condition of continued employment; a current MRPT is preferred
- Bachelor's degree in an associated discipline. Two (2) years’ experience in related field can be substituted for each year of the four (4) years of college. Degree can be waived if certified in one of the following: CQA, CQM, or QMS/LA. ISO 9001:2000 Lead Auditor Training, CMMI, FAA Airframe & Power plant (A&P) Certificate desired
- Extensive experience, eight (8) to ten (10) years in Quality Assurance Auditing and aircraft maintenance
- Experience in risk management processes and techniques desired
- Management experience is desired
17
Quality Assurance Auditor Resume Examples & Samples
- Serves as expert recourse to facilitate and monitor audit staff to ensure appropriate clinical documentation is captured to support diagnosis and to ensure the level of service rendered to all patients is accurately reflected in the record
- Reviews auditor work to ensure audit objectives are met and documentation is compliant
- Monitors, educates, provides feedback, and reports compliance to ensure an effective finding/process as mandated by Compliance and regulatory requirements
- Develops and presents educational sessions to audit staff regarding clinical documentation requirements needed for diagnosis capture, in alignment with regulatory standards and coding guidelines
- Provides expert advice to facility and regional Audit Managers to develop, implement and monitor procedures that support organizational goals and business objectives related to the Revenue Cycle/EIO Audit Programs
- Kaiser Permanente conducts compensation reviews of positions on a routine basis. At any time, Kaiser Permanente reserves the right to reevaluate and change job descriptions, or to change such positions from salaried to hourly pay status. Such changes are generally implemented only after notice is given to affected employees
18
Compliance Quality Assurance Auditor Resume Examples & Samples
- Create and maintain the annual internal audit schedule
- Develop and conduct Internal Audit training as necessary
- Assign the auditors and/or audit teams to each internal audit
- Develop all internal audit plans
- Conduct Opening / Closing meetings
- Lead and/or conduct the audits
- Write and deliver clear, concise audit reports
- Identify needs for corrective and preventive action
- Identify opportunities for improvement
- Facilitate the implementation of improvement opportunities developed as a result of audit findings or audit recommendations
- Support and/or facilitate post-audit process improvement activities
- Report audit status at monthly management reviews
- Monitor and review the audit program
- Evaluate performance of auditors
- Shipment Support Services (provide support services and backup to the Supervisor, Quality Services)
- Bachelors Degree or equivalent experience or Associates Degree with a minimum of four years experience as an Internal Auditor
- Must have a minimum of three years experience in a decision making position (authority to define, execute or control projects/processes and responsibility of outcome)
- Must be an ASQ Certified Quality Auditor or equivalent
- Experience within a manufacturing environment and defense industry desired
- Successful candidates must meet eligibility requirements to access US classified information
- Must have the ability to participate in, lead and facilitate teams
- Knowledge of ISO 9001, 2000, MIL Standards, Defense contracts requirements such as FAR, DPAS, etc
- Proficiency in MS Excel and MS Access
- Works well with management, peers and subordinates
- Experience supervising, coaching and developing staff
19
Quality Assurance Auditor Resume Examples & Samples
- Collaborates with various sites to assure the quality of products, materials, components and/or operations
- Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established standards and agency guidelines
- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and agency guidelines to assure compliance
- Ensures the quality assurance programs and policies are maintained and modified regularly
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
- Monitors performance and supports efforts to develop and implement changes to improve the production process
- Provides constructive evaluation of quality related system investigations including manufacturing sites. - Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet guidelines
- Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
- Follows up with on quality deviations and ensures that solutions are identified and implemented
20
Risk Adjustment Quality Assurance Auditor Resume Examples & Samples
- Assist with execution of Internal Risk Adjustment Coding Review programs
- Performs quality audits on vendor charts as well as Care Delivery coding teams as needed
- Provide ICD10 - CM coding training, as it relates to HCC coding, as requested
- Cross - functional collaboration with multiple teams and functions
- Coding Certification required (CPC, CCS, CCS - P, or RHIT; CPC - A or CCA designation is not acceptable)
- 4+ years recent experience ICD-9 / 10 coding, preferably for a Medicare Advantage health plan, with strong attention to detail and high accuracy rate
- 2+ years recent Medicare Risk Adjustment / HCC Coding experience
- 2+ years recent Provider education experience - communicating directly with providers
- 2+ years experience working in a provider’s office, inpatient setting or a Medicare Advantage health Plan
- Compliant Physician query experience/knowledge
- Proficient knowledge of Medicare Risk Adjustment / CMS - HCC model and guidelines
- ICD - 10 - CM proficient
- Knowledge of HEDIS / STARS
- Normal schedule M - F 8am - 5pm, ability to work a flexible schedule to meet business needs and accommodate meetings in various time zones as needed
- Up to 15% travel (local, non - local meetings)
- ICD - 10 - CM trainer
21
Quality Assurance Auditor Senior Resume Examples & Samples
- Bachelor’s or Master’s Degree
- Certificate, vocational, or college coursework in electrical circuits/electric theory
- ASQ Certified Quality Improvement Associate, Certified Quality Engineer or Certified Quality Manager
- 1 year+ experience as a lead auditor
- 2 years field experience with electric, gas or communications utilities
- Working knowledge of General Orders 95, 128, 165, and 167
- Proficient in Microsoft Outlook, Word, Excel, PowerPoint, Visio and Project
- Proficient in using SAP Work Management module
- Working knowledge of technical/professional concepts (Electric Utility and/or Quality Tools)
- Advanced knowledge of Electric Operation internal compliance requirements (Standards and Procedures - Guidance Documents)
- Guidance Document author training (internal candidates)
- Ability to perform cause analysis
- Ability to present project results to various stakeholders including audit client, audited organization and senior management
- Ability to interact effectively with all personnel levels; including senior management (Director Level) to communicate project findings
- Acts as a subject matter expert and applies extensive knowledge of quality concepts, principles, and practices
- Leads teams of auditors to perform Controls Testing and many audit functions of Electric Operations work groups
- Mentors other less experienced auditors and provides direction with input and guidance from QA supervisor
- Planning and prioritizing work
- Participates in the development/execution of the annual EDC-QA work plan. This includes researching audit archives, project identification, planning, information and data gathering, coordination of interview and site visit scheduling, all associated logistics, and other Control Testing and audit related activities
- Prepares project work package including interviews, checklists, sampling plan, forms, and related records
- Collects, verifies, and analyzes information relevant to project objectives and scope, reviews for understanding regulatory requirements, internal PG&E guidance documents, records, data, and other documents relevant to project scope, objectives and criteria
- Evaluates evidence relative to project criteria to identify observations and findings, including opportunities for improvement
- Communicates project progress to stakeholders and leadership as appropriate
- Develops clearly written reports describing findings, observations, and trends for stakeholder review
- Conducts entrance and exit meetings
- Presents results to various levels of management and follows-up on corrective action activities as needed
- Identifies and conducts project follow-up activities
- Performs cause analysis and identifies linkages to business objectives
- 24x7 On-Call support of CPUC Electrical Incident Reporting (2-3 times per year)
22
Bioresearch Quality Assurance Auditor Resume Examples & Samples
- A minimum of 6 years of experience working in an R&D environment is required
- Experience in the clinical (GCP) OR pharmacovigilance (PV) OR computer systems validation (CSV) area is required. Experience in more than one of the areas is preferred
- Auditing experience in clinical (GCP), pharmacovigilance (PV), and computer systems validation (CSV) space is preferred
- This position will be based in Raritan, NJ, Titusville, NJ, or Springhouse, PA and may require up to 50% overnight domestic and possibly international travel.R&D
23
Senior Quality Assurance Auditor Resume Examples & Samples
- BA/BS degree in the science/health care field or equivalent combined education and experience
- Extensive experience in clinical quality assurance auditing and conduct of vendor audits (e.g. of central laboratories, clinical suppliers, IRBs, etc.)
- Strong knowledge of all applicable Good Clinical Practice regulations and guidelines
- Knowledge of medical terminology preferred
24
Quality Assurance Auditor Resume Examples & Samples
- A college degree in chemistry or related science or an equivalent combination of education and experience
- 1-4 years of auditing, analytical chemistry or related laboratory, or statistical experience is required
- Cooperate with coworkers in an organized team or work independently with minimal supervision
- Positive attitude and ability to work well with others
25
Quality Assurance Auditor Resume Examples & Samples
- The primary focus of this position is to consistently review the performance of completed work for all operational colleagues providing consistent feedback to QA leadership
- Adheres to Quality Assurance measures and metrics which report any trends or process improvement opportunities for each project, office, and RCS division
- Responsible for constant communication with senior leadership regarding quality monitoring results, any identified and/or recommended training needs and deficiencies, as well as possible project improvement opportunities
- Reports all Quality indicators for identification of trends to determine where training deficiencies exist. Implements corrective action plans as necessary to deploy training modules to both individual colleagues and project leadership
- Maintain product knowledge expertise including new product rollouts, upgrades and enhancements
- Must be available to travel up to 25% for on-site Quality support at each service center not to exclude travel to client sites for process review and support of fellow leadership
- Act cooperatively and responsibly with patients, visitors, co-workers, management and clients
- Maintain a professional attitude
- Maintain confidentiality at all times
- Proven oral and written presentation skills
- Minimum of 2 years of experience in Healthcare Patient Financial Services required
- Proven knowledge and experience in all aspects of the healthcare revenue cycle
- Proven ability to effectively lead a group and support fellow leadership members
- Proven knowledge and experience in analytics and problem solving with the ability to recognize trends or anomalies
- Demonstrated ability to work in a team environment that requires quick turnaround and quality output
- Working knowledge of MS Office Products
26
Risk Adjustment Quality Assurance Auditor Resume Examples & Samples
- *This role requires up to 75% local travel
- Coding Certification required (CPC, CCS, CCS-P, or RHIT; CPC - A or CCA designation is not acceptable)
- 4+ years’ experience ICD-9 / 10 coding, preferably in a Managed Care setting, with strong attention to detail and high accuracy rate
- 2+ years’ coding experience in a provider’s office, inpatient setting or a Medicare Advantage health plan setting – can be combined experience
- 2+ years’ Medicare Risk Adjustment experience
- 2+ years’ Provider education experience – communicating directly with providers
- Proficient knowledge of CMS - HCC model and guidelines
- Knowledge of HEDIS /S TARS
- Up to 75% travel (local)
27
Quality Assurance Auditor Resume Examples & Samples
- Skills in planning and performing quality audits, surveillances, and evaluations to applicable procedural requirements
- Demonstrated ability to interface with senior management and clearly communicate issues
- Demonstrated strong teamwork skills
28
Quality Assurance Auditor Resume Examples & Samples
- Assist the QA team with the continuous improvement of a Laboratory Quality System that complies specifically to ISO 17025 and ISO 9001 with Clinical Laboratory Improvements Amendment (CLIA), Good Laboratory Practices (GLP) per 21 CFR Part 58, Good Manufacturing Practices (GMP) per 21 CFR 820, ISO 15189,, as appropriate, by planning and completing audits of laboratory quality systems
- Prepare, review, and/or approve procedures
- Communicate progress orally and in writing with technical monitor and others
29
Quality Assurance Auditor Resume Examples & Samples
- Schedules, prepares, and conducts audits in support of GMP as directed
- Assembles and coordinates the activities of the audit team
- Conducts audits in accordance with Regeneron standard operating procedures and quality policies
- Interprets policies, standards, and regulations, and then evaluates potentially critical problems not covered by the policies, standards, and regulations
- Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance
- Escalates any compliance issues
- Communicates audit results to management and auditees through written audit reports
- Manages post-audit activities, and follows up on any necessary corrective and preventive actions by resolving any conflicts
- Assists with hosting regulatory facility inspections by acting as a scribe and/or document reviewer
- Drafts and issues periodic reports to site management as requested
- Assists with training/orientation for new Quality Auditing staff
- Supervises junior auditors
- *This position requires 40% travel***
- BS/BA with 2-5+ years of related experience in Biotech/Pharmaceutical industry, 2-5 years of audit experience in GMP environment preferred. Other relevant experience may be considered in lieu of degree
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Quality Assurance Auditor Resume Examples & Samples
- Schedules and performs critical phase inspections to ensure compliance with all levels of study staff
- Performs facility inspections, critical phase inspections and data/report audits, which include monitoring for appropriate regulatory compliance, protocol and SOP compliance and reports findings to the appropriate staff and management; verifies actions are implemented and effective
- Audits records and reports for compliance to stated requirements
- Participates in continual process improvement activities for the project and the organization
- May provide backup coverage for other QA functions
- Experience with regulatory or other appropriate guidance documents, i.e. GLP regulations
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Quality Assurance Auditor Resume Examples & Samples
- A community first, company second culture based on Core Values that really matter
- A.D.N degree from accredited school of nursing required; B.S.N preferred; three-year diploma from accredited diploma program may be substituted for nursing degree
- For Applying RN's, current RN license in state of practice required
- Bachelor's degree in associated field preferred
- Minimum of 3 years (5 years preferred) of nephrology experience required
- Experience in researching, updating, and maintaining clinical policies and procedures preferred
- Flexibility in scheduling and ability to travel
- Experience in teaching the adult learner strongly preferred with demonstrated ability to communicate technical/medical information in lay terms as necessary
- CNN or CDN, Bonent certification within one year of hire or position change
- Current driver's license in state of residence and insurable driving record required
- Intermediate computer skills and proficiency in MS Word, Excel, PowerPoint and Outlook required
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Quality Assurance Auditor Resume Examples & Samples
- Daily laboratory audits. This includes, but is not limited to, auditing laboratory practices, equipment use calibration and maintenance, personnel training records, computer security and audit trails, sample receipt and tracking, standard, reagent, and sample preparation and storage, and documentation procedures. Prompt reporting of findings to analysts, lab management
- In-process audits of all ongoing studies, regulated by the FDA, per Good Laboratory Practices (GLP). This includes study audits at all phases of the study, (protocols, methods, forms, sample receipt, SOPs, method validation data and reports, bioanalytical sample analysis data and reports, agricultural sample analysis data and reports, laboratory notebooks, etc.). Prompt reporting of audit findings to clients, analysts, lab management
- Support department goals by reviewing data for consistency, scientific integrity, accuracy, and completeness
- Recommend follow-up action by communicating with Lab Ops staff and management to ensure compliance with GLP, OECD and JMHW standards, regulatory guidelines, and Pyxant Labs SOPs
- Work as a liaison between the QA group, the laboratory personnel and data managers. This includes communicating a consistent quality message and helping to guide and train analysts on all quality related issues
- Serve as a back up to the QA Director on all Document Control (DC) related issues to ensure SOPs, controlled forms, and the master schedule sheet are accurate and current
- The QA Auditor has the qualifications and experience to perform audits, sign off on QA statements, and other functions performed by the QA Unit
- The QA Auditor role requires an appropriate combination of college-level education and technical and regulatory experience related to the work performed at Pyxant Labs
- The candidate must demonstrate proficiency in effective organization and attention to detail to ensure accordance with Pyxant Labs SOPs and regulatory guidelines
- Aptitude in Microsoft Office Suite, including MS Word, MS Excel, MS Access, and MS Outlook is required
- Excellent communication, human interaction, and dispute resolution skills are compulsory
- All roles within the company demand strong team interaction skills, a high level of independence and initiative in work approach, and ability to communicate effectively
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Airlift Quality Assurance Auditor Resume Examples & Samples
- Perform internal evaluations and audits as part of the continuous analysis and surveillance program with respect to the maintenance organization to ensure compliance with operational and regulatory requirements
- Perform technical and regulatory evaluation of maintenance vendors and suppliers, who perform repair and overhaul of aircraft and major assemblies for the company
- BS/BA degree in Aviation Management, Business, or related additional field and/or prior related experience; or equivalent combination of education and experience
- 1-3 years of aviation experience preferred in the areas of safety, audit and or maintenance operations, quality assurance or related function
- Experience conducting quality audits and knowledge of technical auditing principles
- Knowledge of related Federal Aviation Regulations, DOT, and other government regulatory requirements
- Strong written and oral communication skills, including the ability to write technical reports
- Strong computer skills, to include Microsoft products such as Access, Excel, Visio, and Word
- Strong problem solving skills and analytical skills
- Ability to travel domestically and internationally up to 60% of the time
- Excellent interpersonal skills, with the ability to professionally represent AAR Airlift to internal and external entities
- Must have the ability to obtain and maintain a security clearance
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Associate Quality Assurance Auditor Resume Examples & Samples
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification; Associates' degree and relevant experience is acceptable in lieu of Bachelor's degree
- Previous lab or QA experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-1 year) or equivalent combination of education, training, & experience
- Additional experience required(1-3 years) for QA Auditor I level
- Familiar with applicable GxP and appropriate regional regulations (e.g., FDA and other regulatory agency guidelines)
- Thorough working knowledge of Standard Operating Procedures and Working Practice Documents
- Strong attention to detail Able to work independently or in a team environment
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Quality Assurance Auditor Resume Examples & Samples
- Plan, schedule, conduct, report and close audit activities. Audits are conducted to assess compliance with applicable Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) regulations/guidelines, customer requirements, Q2 Solutions’ SOPs and project specific guidelines/instructions
- Conduct study and process inspections of critical bioanalytical phases of non-clinical and clinical studies
- Evaluate audit/inspection findings and prepare and distribute reports to operations staff, management, and customers
- Provide interpretation and consultation to scientific staff on regulations, guidelines, compliance status, and policies and procedures
- Provide consultation to customers in interpretation of audit observations and formulation of corrective action plans
- Review and approve corrective action plans
- Present educational programs related to quality and regulatory compliance
- Host customer audits, and working with operations colleagues, develop corrective action plans
- Assist in hosting regulatory inspections by acting as scribe and/or reviewing documents and identifying and calling operational staff to answer questions as needed
- Lead multifunctional projects related t continuous improvement or processes and systems
- Extensive knowledge of pharmaceutical research and development processes and regulatory environments especially as they relate to laboratory environments
- Knowledge of quality assurance processes and procedures, specifically as they relate to GLP. GMP knowledge also acceptable
- Strong training capabilities
- Ability to manage multiple projects and complete assigned audit tasks in a timely fashion in a high-throughput laboratory environment
- Bachelor’s/primary degree, preferably in a science or engineering field
- 5 years experience in pharmaceutical, technical, or related area
- 3 years in Quality Assurance; GLP or GMP experience; or equivalent combination of education, training and experience
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Quality Assurance Auditor Resume Examples & Samples
- Ability to sit and/or stand at an auditing table for up to 7 hours a day
- Ability to lift piles of garments several times per day
- Ability to read and understand a tape measure
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Senior Quality Assurance Auditor Resume Examples & Samples
- Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions
- Ensure proper conduct of customer-initiated audits and mock regulatory inspections, and assist in regulatory facility inspections
- May perform GLP Archivist duties where needed
- Knowledge of quality assurance processes and procedures
- Effective organization, cOmmunication, and team orientation skills
- Abiility to initiate assigned tasks and to work independently
- 5 years experience in pharmaceutical, technical, or related area, of which 3 years in Quality Assurance; GCP experience (mandatory); or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
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Quality Assurance Auditor Based Livingston Resume Examples & Samples
- Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Quintiles contracts to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions
- Conduct quality assurance activities and projects for clients according to Quintiles departmental or customer policies and procedures within budget and established timelines scheduling, conducting, reporting, and closing audits
- Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by serving as Scribe, reviewing documents and identifying and calling operational staff to answer questions as needed. May host some customer audits independently as directed by QA line management
- Knowledge of word-processing, spreadsheet, and database applications
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Associate Quality Assurance Auditor / Auditor Resume Examples & Samples
- 0-1 years of auditing, analytical chemistry or related laboratory, or statistical experience is required for Associate Level
- 1-2 years of auditing, analytical chemistry or related laboratory, or statistical experience is required for Auditor I level
- Knowledge of chromatography, immunochemistry or statistics and FDA's GLP or GMP (Good Manufacturing Practices) regulations are required
- Manage time effectively
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Quality Assurance Auditor Resume Examples & Samples
- Ensure and audit the site maintains GMP standards
- Ensure and audit processing testing is maintained
- Develop relationships with factory
- Ensure consistent developments with departmental managers
- Develop partnerships with external suppliers / customers
- Challenge and develop and audit systems at Davidstow
- Champion a project and fulfill to completion
- Previous experience required although a good standard of education is essential and also a good knowledge of IT
- 4 G.C.S.E.’s
- Two years experience in the Food Industry,
- Internal Audit Qualified,
- Knowledge of HACCP
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Associate Quality Assurance Auditor Resume Examples & Samples
- Communicate all identified compliance and quality risks to supervisor
- Assist auditors with data audits to assess that the records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures
- Assist auditors with the review of SOPs, protocols/batch records, reports, and other quality and regulated records for accuracy and compliance with all applicable regulations, international standards, and corporate policies and procedures
- Prepare written and signed records of all audits and inspections as required and may sign records as a trainee, countersigned by supervisor/trainer, documenting the performance of audits and inspections and reporting to management
- Assist auditors with preparation for sponsor site visits and the review of QA files; assure that QA audit files are retained
- Assist auditors in identifying, documenting, reporting deviations from regulations, protocols/batch records, SOPs, and specifications
- Perform a preliminary review of protocols/batch records and reports to assure accuracy, completeness, and compliance with regulations, international standards, and company policies and procedures
- Assist auditors with routine monitoring of processes, facilities, equipment, personnel, materials, methods, practices, records, and controls to assure compliance with regulations and international standards
- Experience: 0-1 year experience (this is an entry-level/training position)
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Quality Assurance Auditor Resume Examples & Samples
- Review SOPs, protocols and other controlled documents of basic complexity for compliance with all pertinent GMP regulations and internal policies
- Review and approve or reject all incoming raw material receipt packages for compliance with the requirements detailed in material specifications and applicable testing procedures
- Review environmental monitoring data to ensure levels are in compliance with alert and action limits
- Perform raw data audits of documentation for temperature, humidity, and magnehelic gauges monitoring environmentally controlled areas, and autoclave/oven charts to ensure accuracy and compliance with the GMP regulations, protocols and SOPs
- Review and approve final reports to ensure accuracy and compliance with GMP regulations and the protocols; ensure that the final report accurately describes the raw data and test methods
- Participate in internal audits of Quality Systems and processes to ensure compliance with GMPs and SOPs, including follow-up on corrective action implementation, and effectiveness
- Determine and assure that exception documentation is appropriately reported and documented
- Prepare and review Quality Assurance files prior to Sponsor site visits; ensure that QA audit files are archived
- Provide support during government/agency inspections as requested
- Participate in Quality Assurance projects as requested
- Education: Bachelor’s degree (B.S./B.A.) or equivalent, preferably in a life science or related discipline
- Experience: Minimum of 1 to 2 years in a Quality Assurance role
- Certification/Licensure: N/A
- Other: Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance
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Quality Assurance Auditor Resume Examples & Samples
- Review SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies
- Maintain written and signed records of all audits and inspections as required and may sign records documenting the performance of audits and inspections and reporting to management
- Host client site visits and participate in regulatory inspections
- Coordinate the development of corrective and preventative actions to respond to client visit and regulatory inspection findings
- Provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of regulations and quality principles
- Identify, document, and report deviations from regulations, protocols/batch records, SOPs, and specifications
- Review protocols and batch records and reports to assure accuracy, completeness, and compliance with all regulations, international standards, and company policies and procedures
- Assure the suitability of materials and supplies for compliance with specifications
- Assist with providing basic regulatory training to QA and operations personnel
- Experience: 2-4 years experience in a QA role
- Other: Good working knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Good knowledge of applicable regulations and guidance documents; able to apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing
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Parenteral Quality Assurance Auditor Resume Examples & Samples
- A minimum of a Bachelor’s Degree in Science or Engineering is required. Major in Microbiology, Biology, Chemistry or related field is preferred
- Must have a minimum of three (3) years of overall experience within the pharmaceutical industry
- Working experience in a parenteral area is required
- Experience within Quality area is preferred. Working experience in an aseptic area is a plus
- Knowledge of change control and CAPA. Is required
- Understanding of engineering controls, sterilization and visual inspections
- Must be fluent in English and Spanish (read, write and speak)
- Must be proficient in the use of MS Office software applications. Basic knowledge with Trackwise is preferred
- Availability to work first (1st) and second (2nd) shift is required
- Must be able to work extra hours, at night or on week-ends and irregular shifts, if necessary
- Must be able to travel up to 10% of the time
- The position also involves working in an aseptic area where full gowning is required.Quality Control
45
Parenteral Quality Assurance Auditor Resume Examples & Samples
- A minimum of a Bachelor’s Degree in Science is required. Major in Microbiology, Biology, Chemistry or related field is preferred
- Must have a minimum of seven (7) years of overall experience within the pharmaceutical industry
- Knowledge of change control, CAPA and investigations Is required
46
Clinical Quality Assurance Auditor Resume Examples & Samples
- Provides audit reports to management
- Plans and delivers quality services for contracted quality assurance audits, internal site audits, laboratory and file audits for clients and projects
- Additional audits to include database, CSR, ETMF, various vendors and government trial sites
- Conducts and/or leads a variety of client, internal or GCP audits and regulatory inspections as requested by senior management
- Leads directed site audits, facility, vendor and/or sub-contractor audits
- System audits
- Departmental, internal operations or client meetings
- Provides mentorship and guidance to junior auditors
- Candidates with government audit and trial experience are highly preferred. BARDA, DAIDS, US Army, NIH, FDA, CDC, etc
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Associate Quality Assurance Auditor Resume Examples & Samples
- Education:Bachelor’s degree (B.S./B.A.) or equivalent, preferably in a life science or related discipline
- Experience:Entry level - 0+ year experience
- Certification/Licensure:N/A
- Other:Knowledge of Microsoft Office ® applications and spreadsheet programs such as Access and Excel. This position requires the individual to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements and effectively communicate (written and oral) findings
48
Quality Assurance Auditor Resume Examples & Samples
- Generation and distribution of NCMR's for specific area -- QAP's and MPS's
- Audits the production process to confirm that Device History Records are completed according to Device Master Record/QSR/GMP regulations
- Audits finished products to ensure that it conforms with Device History Records/applicable specification and procedures
- Performs work order reviews for ECN's, EPWO's, NCMR's, etc
- Documents inspections/rejections on inspection paperwork
- Initiates and ensures closure of NCMR's
- Accountable for the disposition agreement/verification of NCMR's
- Operates complex testing equipment in verifying that final product meet specification
- Performs dimensional inspections
- Initiates and makes copies of final inspection paperwork
- Tracks and maintains NCMR's and material testing products
- Submits materials for MEM/IR testing
- Quarantines product when discrepancies are noted
- Performs other related quality auditing tasks, as required
- IQA
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Quality Assurance Auditor Resume Examples & Samples
- Accurately audits loans to determine documents, data and conditions support data submitted through AU system
- Audits for data integrity and accuracy, including recalculation and reverification of income, employment, assets, identity and occupancy
- Ensures that loans meet agency, investor, Supreme Lending and program guidelines as well as regulatory compliance requirements
- Assists in the review of cancellations, rejections, early payment defaults, early foreclosures, and special requests as needed
- Maintains a professional image and adheres to standards consistent with company policies and procedures
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Quality Assurance Auditor Resume Examples & Samples
- Develop presentations in MS PowerPoint and conduct briefings to project stakeholders
- Master’s Degree and 4 years of relevant work experience or a Bachelor’s Degree and 6 years of relevant work experience, or 10 years of experience as a Auditor in requirements gathering and documentation, process flow and process modeling in lieu of a degree
- 4 years’ experience of System Development Life Cycle (SDLC) methodologies (such as Agile or Waterfall models)
- 1 years’ experience performing QA audit in an IT environment for waterfall and Agile projects
- 1 years’ experience performing business and systems analysis for systems that cross multiple components and impact multiple systems
- 1 years’ experience in requirements gathering and documentation, developing use cases, functional specifications and detailed design documents; and developing test cases
- Able to obtain a Position of Public Trust designation
- Master’s Degree and 7 years of relevant work experience or a Bachelor’s Degree and 9 years of relevant work experience, or 13 years of experience as a Auditor in requirements gathering and documentation, process flow and process modeling in lieu of a degree
- 3 years’ experience performing business and systems analysis for systems that cross multiple components and impact multiple systems
- Solid experience on SDLC methodologies (such as Agile or Waterfall models) and QA audit tools
- Certification in Project Management (PMP), Agile, QA, or Business Process Improvement
- Directed and administered critical projects to completion, overseeing resource optimization, process re-engineering, systems analysis/design, end-user training, and technical troubleshooting
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Quality Assurance Auditor Resume Examples & Samples
- Provide leadership and consulting regarding regulatory inspection preparation as well as support to internal PPD staff during investigator site, sponsor facility, and PPD facility inspections. Provide routine updates to senior management within PPD regarding inspection status and outcomes. Assist client/internal teams with regulatory authority inspection responses when requested. Assist client/internal teams in development of regulatory notification letters as needed
- Candidates with directed audit, pre-inspection audit and inspection support experience are preferred
- Able to demonstrate proficiency and lead a range of project based or internal GxP audits and vendor audits to high standards required by management
52
Quality Assurance Auditor Resume Examples & Samples
- Works with the Regional Director and Sales Representatives to establish and maintain close relationships with new customers and existing accounts by being involved to the appropriate degree in the following
- Education and/or experience equivalent to a related "Bachelor's degree
- Ability to communicate effectively with and to understand the needs of others in a sales relationship
- A high degree of personal motivation and drive to achieve personal and professional goals
- Excellent oral presentation skills and the ability to think quickly to apply facts in analyzing a problem and explaining that answer to a group of medical technicians and clinicians
- Ability to learn the usage of medical equipment and to identify and explain possible improvements in usage
- Ability to work effectively as a team member to achieve organization goals
- Ability to utilize business mathematics to figure percentages, prepare financial and sales information
- A high degree of personal organization skills, including the ability to record and report information and to document work performed
- Ability to work independently with a minimum of supervision
- Ability to travel extensively and work long hours to achieve goals, as required
- Excellent driving record with no driving accidents in the past three years or no more than one driving ticket in the last three years
- Prefer one to two years of direct sales experience
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Quality Assurance Auditor Resume Examples & Samples
- A BS degree in chemistry, biology or related lab science or health science
- Or an equivalent combination of education and experience
- Experience with reviewing data a plus
- Strong computer skills including MS Office (Word, Excel needed)
- Experience working in a deadline driven environment
- Strong attention to detail with ability to multitask as needed
- Ability to work collaboratively within a team environment
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Quality Assurance Auditor Resume Examples & Samples
- Strong knowledge of process design and controls
- Ability to conduct an analysis of a business need, including scheduling
- Comprehensive knowledge of products, regulatory standards (e.g. FDCPA, UDAAP, FCRA, SCRA), policies and procedures applicable to assigned area
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Quality Assurance Auditor / Senior QA Auditor Resume Examples & Samples
- Bachelor’s degree in relevant field and 3 years of relevent experience; or
- HS/GED and 6 years of relevant regulatory auditing experience
- Computer skills, commensurate with Essential Functions and including ability to learn a validated system
- Ability to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended shifts and/or extra shifts, sometimes on short notice
- Ability to work under specific time constraints
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Claims Quality Assurance Auditor Resume Examples & Samples
- Bachelors Degree or equivalent combination of education and work experience
- 2 years relevant or Lender Placed claim handling experience
- Experience with quality assurance initiatives or experience with process improvement and data analysis
- Working knowledge of claims insurance industry products and services
- Working knowledge of quality assurance procedures and continuous improvement techniques and principles
- Working knowledge of database systems, applications and technology relevant to area of responsibility
- Working knowledge of Microsoft Outlook, Word, Excel and Access
- Working knowledge of test and inspection methods
- Effectively communicate ideas to key stakeholders to influence adoption of innovative solutions
- Analyze and synthesize data to form options and recommendations
- Conduct tests and inspections of services or processes to evaluate quality or performance
- Ability to anticipate obstacles and challenges, identify root cause and strategize plans to address
- Manage and prioritize competing responsibilities concurrently and effectively
- Conduct gap analysis of current state and desired future state
- Assist with defining a project's scope
- Communicate complex information in user-friendly format
- Work independently with little supervision or direction
- Organize people, tasks and activities to yield efficient work flow
- Adjust plans, goals, actions or priorities to meet changing situations; adapt and be flexible in a complex, changing work environment
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Quality Assurance Auditor Resume Examples & Samples
- Education and experience equivalent to a high school diploma and a minimum of two years of related work experience with one of the years being in quality assurance/quality control work experience
- Demonstrated knowledge of business mathematics
- Excellent attention to detail and the ability to meet deadlines in a timely manner
- Communication and interpersonal skills and the ability to work well with others
- Demonstrates the ability to operate complex test equipment
- Able to perform all Quality Assurance Auditor functions for one of the following areas
- Clean Room
- Molding
- Label Control
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Quality Assurance Auditor Resume Examples & Samples
- Provide technical expertise in the development and implementation of the company's QA/QC program. Collaborate with outside agencies as required
- Support compliance and quality functions in the review and timely execution of federal and state codes and regulations in regard to gas pipeline and distribution systems
- Develop, implement and oversee QA/QC audits in order to determine company-wide levels of compliance with state and federal pipeline safety laws and company procedures
- Identify operational safety and quality concerns and develop recommendations to improve internal controls to maximize effectiveness and efficiency. Determines where existing policies/procedures require change or when new one needs to be developed
- Available for on-call, emergency response, incident investigation and regulation reporting responsibility. Responsible for performing root cause analysis for various incidents, including safety related incidents
- Coordinate the QA/QC activities for SJG with other groups e.g. Construction Inspectors
- Evaluate the training, recordkeeping and implementation of the Operator Qualification (OQ) requirements as they relate to field workforce. Interact with other Companies including New Jersey LDC’s to maintain and evaluate proper uniformity in QA activities. Interact with the BPU on Inspections
- Evaluate through QA inspections, the distribution department’s training activities to assure that operating methods are implemented and executed across all lines of the operating department
- Conduct studies of a technical nature and/or participate in special task forces as assigned that will result in long range efficiencies to the QA/QC, Safety and Technical Training functions. Make recommendations that can be used to develop long-range plans in operations
- Assist in the development of budgets for the QA department
- Perform duties inherent in all supervisory, professional and administrative positions. Consistent with all positions in this classification, additional projects, tasks and/or duties beyond what is outlined here may be assigned as required
- Bachelors degree in engineering, construction or related field is preferred
- QA/QC and/or technical training experience related to utility operations strongly desired
- Demonstrated ability to successfully implement a QA/QC program in a utility environment is strongly desired
- Understanding of safety, QA/QC and training requirements and regulations for a gas distribution utility
- Working knowledge of Microsoft programs including: Word, Excel, Access and PowerPoint
- Good analytical and problem solving skills required
- Explore the Possibilities
- We are committed to developing and implementing innovative projects that increase energy efficiency and save clients money
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Senior Quality Assurance Auditor Resume Examples & Samples
- Review/approve SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies
- Participate in the preparation and review of study and QA files in preparation for sponsor site visits and regulatory inspections; assure that QA audit files are retained. May host client site visits and manage regulatory inspections
- Develop recommendations for corrective and preventative actions to respond to client visit and regulatory inspection findings. May coordinate the drafting of correspondence responding to client visits and regulatory inspections
- Routinely provide recommendations to Regulatory Affairs and Compliance management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of regulations and quality principles
- Assist in scheduling and tracking QA audits, inspections and procedures as requested
- In GMP facilities, review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product
- Perform all other related duties as assigned
- Education: Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline
- Experience: 3-5 years experience in a QA role
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Claims Quality Assurance Auditor Resume Examples & Samples
- Audits claims in accordance with departmental policies and procedures and other rules applicable to specialty claims
- Must be able to identify provider, member, and/or system issues
- Must be able to process DME and chemotherapy and other drug claims, as well as calculate anesthesia time by reviewing medical records
- Attends organizational meetings as required
- Adheres to organizational policies and procedures. Keep updated materials and resources provided for accurate and expedient adjudication
- Must audit 25% open claims and provide auditors with observations/corrections
- Must be able to identify root causes for deficiencies found
- Provides management with training recommendations
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Quality Assurance Auditor Resume Examples & Samples
- Operates basic testing equipment in verifying that final product meet specification
- Education and experience equivalent to a High School Diploma with a minimum of one year of related experience
- Ability to learn to operate basic test equipment
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Quality Assurance Auditor Resume Examples & Samples
- Review and disposition of quality events, deviations and product risk assessments
- Evaluation of change proposals in Reliance change management system
- Assist in investigation and corrective action tracking and closure
- Primary source for compliance guidance to IPT
- Other duties may include
- Seed Management
- Maintaining data and Metrics
- Quality improvement projects
- Other assignments as given
- Working knowledge of good manufacturing practices and quality management systems
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Quality Assurance Auditor Resume Examples & Samples
- Maintenance of site HACCP documentation of product quality
- Audit of site HACCP product quality system
- Audit the process against agrees standards/manufacturing specification
- Audit the site’s process control system in operation and the associated paperwork; these will include aspects of product quality, (and legal standards and food safety). This will involve observing that the checks and records are being completed and carrying out independent validation checks for some activities
- Audit the key process line activity of product attribute monitoring
- Audit the components of the company’s QMS appropriate to site
- Audit final product quality standards ; organoleptic, packaging etc
- Taste panel sampling (together with nominated team) and shelf life monitoring
- Audit that the site’s system for non-compliance and incident control are being effectively managed
- Audit the site’s training procedures and achievements against plan
- Maintenance of site HACCP documentation for Food Safety
- Audit of site’s HACCP food safety system
- Audit the site’s operational housekeeping and hygiene standards
- Audit the site’s personnel hygiene standards; including laundry activities
- Audit the site’s systems for site induction and training; employee illness control etc
- Audit the site’s routine ‘clean as you go’ day cleaning activities
- Audit of specific policies and procedures relating to food safety; e.g. nut policy, glass policy
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Claims Quality Assurance Auditor Resume Examples & Samples
- Responsible for providing all Audit functions across the Claims organization
- Evaluate Claims files against established best practices and Claims guidelines for accuracy
- Aggregate results for all QA Audit measurements performed and share with key business leaders in the Claims Technical team
- Develop calibration measurements, score cards, action plans and best practice methods to mitigate risks in the claims handling process
- Develop the QA questionnaires that will be used, and coordinate those efforts with the Claims Technical team to ensure process improvements are documented and accurately captured
- Revise and review Claims guidelines as needed, and to support the continuous improvement efforts of the operation
- Contribute to a positive work environment by demonstrating cultural expectations and influencing others to reward performance and value “can do” people, accountability, diversity and inclusion, flexibility, continuous improvement, collaboration, creativity and fun
- 2 years relevant experience
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Quality Assurance Auditor Resume Examples & Samples
- At least 2+ years of experience working in relevant field such as investigations, auditing, project/program management, etc
- Working knowledge of Excel and SharePoint
- Strong critical thinker with the vision to work both tactically and strategically
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Quality Assurance Auditor Resume Examples & Samples
- Follow safety guidelines and report any problems immediately
- Performs product inspections per procedures for Molding and Assembly Operations, including DOA lines
- Ensures defects found are corrected and questionable product is quarantined or sorted
- Work with maintenance and operation personnel when defects or problems are found
- Follow up to insure proper actions were taken to correct problems found
- Product Disposition of Assemblies, ensure quarantined and/or scrap product is moved to correct location and all records are accurate and complete
- Assist with maintaining quarantine (verify, disposition, sort as required, etc.)
- Maintain Customer Controlled Products per procedures
- Prepare necessary paperwork and reports. In addition data entery will be required
- Assist in other jobs performed by Quality associates as needed, including covering for PTO. This will require working 12 hour shifts on both days and nights, as required
- Works with Quality Assurance Manager on development of new testing
- High School Education or GED Equivalent
- Prior Quality Assurance Experience preferred
- Good Interpersonal Skills
- Good Computer Skills Preferred
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Quality Assurance Auditor Resume Examples & Samples
- Maintain competency and understanding of quality requirements for laboratory accreditation agencies, including CAP/CLIA, NYSDOH, NLCP and others
- Monitor the laboratory to assure laboratory management that equipment, methods, practices, records, controls, and SOPs are in compliance with regulations and accreditation requirements
- Report all findings to management through internal audit reports
- Follow-up on corrective/remedial actions to assure appropriate actions were taken and were effective
- Aid directors, managers, and supervisory personnel in preparing for inspections. Actively participate in all audits and inspections, as directed
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Quality Assurance Auditor Resume Examples & Samples
- Monitor plant sanitation and personal hygiene as outline by Good Manufacturing Practices (GMPs) for food processing facilities in CFR (Title 21, part 117) and current company GMP Policies
- Standardized and calibrate laboratory equipment, troubleshoot systems, equipment and processes
- Actively participate in continuous improvement, lean practices, six sigma, 5S, food safety, environmental and plant safety programs
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Quality Assurance Auditor Resume Examples & Samples
- Plan, schedule, conduct, report and close assigned audit activities in any of the countries involved with Quintiles contracts to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions
- Represent quality assurance program on customer and project teams under the direction of more senior QA staff
- Enhance and maintain a working knowledge of relevant GXP regulations
- Bachelor’s/primary Life Science degree with experience in pharmaceutical, technical, or related area including GXP and/or Quality Assurance experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
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Quality Assurance Auditor Resume Examples & Samples
- Bachelor's degree in Medical Technology or equivalent
- 1 to 5 plus years of previous QA experience highly preferred
- 1 to 4 years of Medical Technology bench experience required in a CAP/SANAS accredited / CLIA certified laboratory setting
- Registration with the Health Professions Council (HPCSA) as a Clinical Pathology Medical Technologist or the American Society of Clinical Pathology (ASCP), at a generalist level
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Quality Assurance Auditor Resume Examples & Samples
- Must have a minimum of5years’ experience
- Four year college degree in; Bachelor’s Degree, Engineering, Construction Management is PREFERRED
- Experience supporting PennDOT and / or Port Authority of Allegheny County projects
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Quality Assurance Auditor Resume Examples & Samples
- As a QA Auditor obtaining and maintaining qualification as a QA Auditor
- Under the guidance of the QA Audit Manager or assigned Audit Team Leader, plan, perform and report on the results of assigned QA Audits and Assessments
- Verifying the adequacy, implementation, and effectiveness of the WTP QA program for activities and report the results to management
- Verifying the adequacy, implementation, and effectiveness of Q-Supplier's QA programs and report the results to management
- Develop and execute risk-based quality assurance audit and surveillance checklists
- Ensure that deficiencies and enhancements identified by the QA Audit group are appropriately documented
- Assist with preparation of internal quality assessment related procedures
- Follow up on corrective actions for QA-identified issues to verify adequacy and sustainability
- Assist in the development of and maintain metrics related to the Quality Audit group's scope of work; Support the Waste Treatment Plant Nuclear Safety Quality Culture by emphasizing the values of safety and quality in the performance of work in order to protect self, others, and the environment
- This job description is not intended to include every duty, task or instruction for which an employee is responsible. Other tasks may be assigned, based on business needs and the department supervisors request
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Quality Assurance Auditor Resume Examples & Samples
- 1 to 4 years of Medical Technology bench experience required in a certified laboratory setting
- Preferably bilingual with French being the other language
- Valid driver's license and passport
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Quality Assurance Auditor Resume Examples & Samples
- Assists in the training of quality assurance auditors when necessary
- Writes audit reports and coordinates district level corrective actions
- Assists Regional Managers with self-audit and inspection processes
- Supports quality awards programs
- Supports the service delivery, complaint resolution, sales, product development and client retention processes
- Participates in calibration exercises with team members
- Assists in formulating and coordinating branch level quality processes
- Upholds the Crawford Code of Conduct
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Senior Claims Quality Assurance Auditor Resume Examples & Samples
- May act as a lead analyst who can direct the activity of quality assurance auditors and coordinate activity associated with a district quality review
- Interacts with clients in matters of quality analysis
- Analyzes and evaluates the effectiveness of quality programs and projects
- Assists development and maintenance of documents and tools to complement quality programs on all domestic operations
- Conducts calibration exercises with team members
- Communicates the corporate quality message to stakeholders
- Designs and conducts quality audits; determines quality score
- Trains, mentors and certifies quality assurance analysts
- Trains managers, supervisors, and staff in quality programs and corrective actions
- Writes and approves audit reports and coordinates district level corrective actions
- Analyzes, reports, and delivers quality information and the results of quality programs and projects
- Polls, surveys, and gathers customer and employee satisfaction information
- Remediates quality problems under the auspices of national, regional or local initiatives
- Supports the service delivery, internal & external complaint resolution, sales, product development and client retention processes
- Hosts or supports community forums
- Participates in special projects or performs duties in other areas as requested
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Quality Assurance Auditor Resume Examples & Samples
- Two years’ experience handling multiple simultaneous assignments with minimal supervision and in coordinating activities with various levels of management
- Proficient in using multiple automated aircraft maintenance technical forecasting, tracking, routing, and reporting databases (Such as SABRE, SCEPTRE)
- Strong written, verbal, presentation and interpersonal skills
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Associate Quality Assurance Auditor, Based Resume Examples & Samples
- Assist in conducting quality assurance audits within budget and established timelines by scheduling, conducting, reporting, and closing audits as directed by the lead auditor. Activities may include contacting auditees to agree on audit dates, making appropriate entries in QA database (audit demographics, dates, and personnel,), performing data reviews, file audits, etc. as directed, entering and categorizing audit findings in the QA audit tracking database, soliciting follow-up information and closing audits/findings in the QA database
- Document and report quality and compliance issues to QA line management within specified regional timelines
- Assist in hosting customer audits, mock regulatory inspections, and regulatory facility inspections by acting as a scribe, review documents, and identifying and calling operational staff to answer related questions and performing required administrative duties including tracking of documents reviewed, scheduling audit team members for interviews and coping and stamping documents for release to the auditors/inspectors
- Obtain a fundamental knowledge of current relevant GXP regulations, guidelines, and related auditing techniques
- Knowledge of GXP regulations and guidelines and basic auditing techniques
- Ability to establish and maintain effective working relationships with co-workers, managers and clients
- Bachelor's degree in a relevant life science preferably with some Quality based experience or a combination of education, training and experience
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Quality Assurance Auditor Resume Examples & Samples
- Audit the site's process control system in operation and the associated paperwork; these will include aspects of product quality, (and legal standards and food safety). This will involve observing that the checks and records are being completed and carrying out independent validation checks for some activities
- Audit the components of the company's QMS appropriate to site
- Audit final product quality standards; organoleptic, packaging etc
- Audit that the site's system for non-compliance and incident control are being effectively managed
- Audit the site's training procedures and achievements against plan
- Audit of site's HACCP food safety system
- Audit the site's operational housekeeping and hygiene standards
- Audit the site's personnel hygiene standards; including laundry activities
- Audit the site's systems for site induction and training; employee illness control etc
- Audit the site's routine 'clean as you go' day cleaning activities
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Risk Adjustment Quality Assurance Auditor Resume Examples & Samples
- Associates’ degree or higher
- 5+ years of recent experience ICD - 9/10 coding, preferably in a Managed Care setting, with strong attention to detail and high accuracy rate
- 2+ years of coding experience working in a provider’s office or for a Medicare Advantage health plan
- 1+ years of recent experience in a coding auditor role
- 2+ years of recent Medicare Risk Adjustment experience
- 2+ years of Provider interaction - communicating directly with providers
- Normal schedule M-F 8am-5pm with the ability to work a flexible schedule to meet business needs and accommodate meetings in various time zones as needed
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Quality Assurance Auditor Resume Examples & Samples
- Must hold and maintain a Registered Nursing License, or license or certification in related field
- Must have strong knowledge of medical terminology, anatomy and physiology, treatment protocols, medications and laboratory values
- Must be able to add, subtract, multiply, and divide in all units of measure, using whole numbers and decimals; Ability to compute rates and percentages
- Must be able to stay focused and concentrate with frequent interruptions
- Must be able to work well under pressure and or stressful conditions
- Must maintain a professional and clean appearance at all times consistent with company standards
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Clinical Quality Assurance Auditor Resume Examples & Samples
- Bachelor’s degree in Healthcare or equivalent experience required, with a current Tennessee RN license
- A minimum of 5 years broad scope health care experience and 1 year experience in review and analysis of medical records required
- Certification as a Professional in Healthcare Quality is desired, or actively pursued within 2 years of obtaining position
- Proven ability to consistently represent BCBST in a professional manner
- Outstanding ability to analyze, plan, resolve problems and communicate effectively required
- High degree of autonomy and initiative with proven outcomes to meet department and regional goals
- Excellent written and oral communication skills (including presentation and team facilitation)
- Demonstrated ability to mentor others in the roles/responsibilities of Clinical Audit
- Team player with ability to consistently collaborate with internal and external department staff to meet department and organization goals
- Computer proficiency with broad knowledge of applications that include experience in MS Office, Word, and Excel required, with claims and/or credential software experience preferred
- Demonstrated knowledge and ability to integrate applicable contractual, accrediting and regulatory guidelines to review responsibilities required
- Valid driver’s license and automobile for routine travel, with occasional overnight travel required
- High degree of flexibility and ability to accommodate regional review and project needs to meet critical deadlines during annual required HEDIS project
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Quality Assurance Auditor Resume Examples & Samples
- Using mechanical metrology equipment, perform product and component audits to ensure compliance with applicable technical and engineering documentation
- Working within Quality leadership, establish a highly effective Internal Audit and Corrective and Prevention Action (CAPA) program
- In collaboration with plant Production and Engineering functions, troubleshoot mechanical, electrical, hydraulic and electronic equipment using technical documentation
- Perform root cause failure mode analysis and communicate irreversible corrective actions to Quality, Production and Engineering leadership
- Using statistical methods, perform trend analysis of component critical characteristics to provide early detection of potential systems failure
- Perform Quality Management Systems audits and report findings in a clear, concise manner to plant and company leadership
- Interface with regulatory and customer auditors in a manner that reflects positively on the company
- Associates degree or Technical School education preferred
- Two (2) years in a quality control/assurance role
- Demonstrated ability to read mechanical and electrical blueprints
- Demonstrated technical understanding of mechanical and/or engineered components including: gearboxes, bearings, rotating equipment, hydraulic systems and control systems
- Ability to work with engineering function to troubleshoot technical issues
- Excellent computer skills to include MS Office, Minitab or other statistical analysis program
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Quality Assurance Auditor Resume Examples & Samples
- Carrying out numerous call assessments on a daily/weekly basis
- Carrying out numerous account audit assessments on a daily/weekly basis
- Managing investigation into supplier related consumer complaints to understand root cause and required mitigation
- Support the process of reviewing, seeking approval and recording consumer correspondence suites
- Calibration activity across the supplier panel
- Responsible for owning and delivering client agency audit service level agreements (SLA) including client reporting details and client calibration meetings
- Produce quality MI for conduct performance in an accurate and timely manner
- Support preparation and, where required, support debt collection agency on-site audits and carry out reviews in conjunction with other members of the team
- Support the team on change management to continuously develop standards of quality and consistency within the team Manage day-to-day queries and insights as required by the wider organisation
- Support the 3rd party conduct & oversight team’s vision as best-in-class; provide input in continuing to uphold its values, orientation and reputation
- Works in a consumer and customer oriented environment
- Can demonstrate an ability to adapt knowledge in new environments, experience working in a regulated environment would be preferred but not essential
- Has proven an ability to assess consumer related activity and articulate findings with self-confidence using collaborative and pro-active measures
- Measuring and managing quality assurance and compliance on customer calls and account activity
- A confident individual who can work on their own initiative
- Plans and prepares meticulously and manages own workload
- Able to rationalise and summarise qualitative activities
- Good written and verbal communication skills that demonstrate a passion for the consumer, compliance and customer experience
- Client driven with an ability to work well under pressure
- Experience of managing stakeholder requirements and expectations
- Proficient in Microsoft computer applications
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Quality Assurance Auditor Resume Examples & Samples
- Audits a variety of methodologies as applied to various stages of pharmaceutical development
- Verifies accurate transcription of raw data into reports
- Audits testing for compliance to all applicable SOPs and protocols
- Familiarity with Empower 3 software and at least one scientific technique (HPLC, GC, etc.)
- Discusses notebook issues with responsible lab analyst
- Trains other in the QA group at the discretion of the QA Management
- Support Control document unit functions as needed
- Identifies compliance issues
- Participates on assigned teams as required
- Solid understanding of chemistry/lab practices
- Knowledge of auditing techniques
- Familiarity with Empower 3 software at least one scientific technique (HPLC, GC, etc.)
- Associates, Bachelors or Master’s degree in Chemistry or closely related physical science field from a four year college/university or equivalent education and job experience
- Minimum experience of two years in a regulated industry
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Quality Assurance Auditor Resume Examples & Samples
- Participate in the preparation and review of study/batch record and QA files in preparation for sponsor/client site visits; assure that QA audit files are retained. May participate in the hosting of client site visits and support regulatory inspections
- Participate in the development of corrective and preventative actions to respond to client visit and regulatory inspection findings
- Assist in providing basic regulatory training to operations personnel
- Maintain written records for all statistical sampling and testing of product if tested in manufacturing areas
- Participate in manufacturing line clearances and verification of room acceptability prior to product manufacture
- Participate in Regulatory Affairs and Compliance projects
- Education:Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline
- Experience: 1-2 years experience in QA role
- Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate findings verbally and in writing
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Risk Adjustment Quality Assurance Auditor Resume Examples & Samples
- Performs ONSITE concurrent coding quality reviews for provider charts as well as other teams as needed
- Evaluates documentation to ensure that diagnosis coding is supported and meets specificity requirements for accurate submissions
- Queries providers regarding missing, unclear, or conflicting health record documentation by requesting and obtaining additional documentation within the heath record
- Provides coaching and feedback and develops targeted education and training to provider teams to improve accuracy
- Develops relationships with clinicians and communicates guidelines and requirements of Risk Adjustment Payment System to ensure correct coding and documentation
- Develops relationships with clinical providers and communicates coding and documentation guidelines and requirements of the Risk Adjustment program to ensure correct coding and documentation
- Maintains a 95% quality audit accuracy rate
- Takes direction and guidance from Supervisor of the Risk Adjustment Coding and Documentation Improvement Specialist and the Manager of the Risk Adjustment Coding and Documentation Improvement Program
- Associates degree or higher or significant equivalent work experience
- Coding Certification from AAPC or AHIMA, (CPC, CPC-H, CPC-P, RHIT, RHIA, CCS, CCS-P)
- Clinical Documentation Improvement Specialist Credential AHIMA or ACDIS
- Certification as Certified Risk Adjustment Coder (CRC)
- 1 year experience as Risk Adjustment Quality Auditor
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Clinical Quality Assurance Auditor RN Resume Examples & Samples
- The Clinical Auditor will conduct, review, analyze and summarize findings of audit plans for internal business units and delegated partners and entities on a monthly, quarterly and/or annual basis. Focuses specifically on CCMS (CareEnhance Clinical Management Software) assessments, supporting documentations and authorization to ensure compliance with regulation, policy and procedures. This includes collecting, aggregating, sorting and communicating summary of data collected and utilizing excel pivot tables, charts and graphs to share findings and prepare materials for reporting purposes
- Assist with evaluating and analyzing ad hoc quality performance data to develop strategies for implementing Performance Improvement initiatives. This includes: identifying opportunities for improvement, problem prioritization and creating performance improvement plans for non-compliant audits and/or reports
- Contribute creative solutions and ownership of daily assignments for seamless communication and systematic completion of routine and special projects
- Working under the direction of the Director, maneuvers multiple tasks independently with a fast-paced proactive vs. reactive approach to changing priorities
- Maintain tracking tools that will log unacceptable areas in the workflow and staff documentation performance indicating improvement is needed for discussion with management and/or at departmental team meetings
- Assist departments with creating and revising audit tools, as necessary, to ensure audits and reports are value added to the business(s) owner
- Associate’s degree from an accredited institution
- Licensed Practical Nurse (LPN) or Registered Professional Nurse (RN) License
- Experience in medical records review, claims processing or utilization/case management in a clinical practice or managed care organization. This should include experience analyzing various types of data and processes with ability to present findings and recommendations
- Ability to use Microsoft programs, including Word, Excel and Powerpoint
- Experience working with one or more of the following systems: Basic Adobe Reader or Writer; CareEnhance Clinical Management Software (CCMS); Citrix; e-fax (RightFax); encryption security tools; Sunguard Macess Service Module (electronic archiving); Virtual work platforms (VPN), VoIP and / or claims system (MHS)
- Bachelor’s Degree and RN License with work experience in medical records review, claims processing or utilization/case management in a clinical practice or managed care organization to include experience as a trainer or preceptor to staff or a third party
- Proficiency with healthcare terminology such as ICD 9 codes, medical abbreviations, medications
- Knowledge of Professional Nurses ANA Code. Knowledge of regulations established and issued by the Department of Health (DOH) and Center for Medicare & Medicaid Services (CMS)
- Aptitude for formulating and reporting results based on fact finding.Certification courses or other higher education in nursing, healthcare administration, business, operations management or other related discipline
- Working in a home care environment or as a staff nurse in an acute, sub-acute or long-term care (LTC) setting or managed long-term care plan (MLTCP); Geriatrics, Medical Surgical Nursing, Case Management or Discharge Planning
- Knowledge of Department of Health (DOH) and Local Department of Social Services and Center for Medicare & Medicaid Services (CMS regulations)
- Experience with Medicaid managed care plan products such as Family Health Plus (FHP), Eastern Benefits System (EBS), Federal Employee Program (FEP)
- Bilingual language preferences: Spanish, Russian, French, Creole, Mandarin, Shanghainese, Suzho, Cantonese, Toishanese, Fujianese, Fukanese, Fuzhonese Hindi, Bengali, Urdu or Nepali
- Ability to build and maintain positive relationships with internal staff and interact with all levels of management
- Ability to communicate complex information orally and in writing using proper grammar and correct spelling
- Experience working independently and in a team, as well as, following and executing detailed specific directions
- Able to multi-task, organize granular details and independently manage time. Ability to problem-solve and show diplomacy in an environment containing frequent interruptions, changing priorities and short deadlines
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Quality Assurance Auditor Resume Examples & Samples
- Inspect and audit processes and products to ensure they conform to the company's quality standards
- Under the leadership of the Quality Manager, assist the organization in monitoring production and process quality levels through selective inspections and regular audits
- Identify quality problems and make improvements
- Train staff involved in the processes
- Ensure that production operators have the necessary tools to properly perform their job, in conjunction with Team Leaders/Supervisors
- Work with Production Supervisor on daily scheduling at GP12/CARE Inspection and manage GP-12/CARE containment activity
- Perform receiving inspection/dock audits for incoming/outgoing material according to the audit plan
- Work with Team Leaders/Supervisors to audit and train Operators to ensure compliance to standard work procedures and quality related instructions
- Perform product and process audits and ensure that product and processes are conforming to specifications
- Initiate and complete containment activities for all internal and external customer concerns, broken tool audits, non-conformances, coordinate response to SPC out of condition, in conjunction with Team Leaders/Supervisors and Operators
- Update and review I charts/ P charts and prepare report for fast response meeting (findings and defect free inspection days)
- Perform in process/ final operation/ inspection audits using metrology equipment: CMM, Height Gauges, Hardness tester, profile-meter, surface tester, Shadow graph, etc. as required
- Responsible for ensuring product quality and authorized to stop production to correct quality problems
- Promptly notify immediate Team Leader, Supervisor, or Manager for products or processes which do not conform to requirements
- Issue Quality Alerts, perform training and ensure operators are aware of Quality Alerts, temporary deviations, and approved process or product changes
- Investigate and trouble-shoot all quality concerns and ensure that all non-conformances are reported as per procedure thru NCR or DMN as required
- Help in departmental targets to lower incidence and cost of Quality
- Interact with Production Manager, Production Supervisor, Team Leaders, Production Operators, as well as Tool room, Maintenance, and Engineering departments as required
- Assist/ participate in APQP activities on existing or new programs for process capability studies, gauge R&R, PPAP sample run parts, trials etc
- Perform Layered audits as per schedule
- Prioritize and complete daily and unforeseen tasks
- Involvement in supplier quality related production issues, coordinates sorts for non-conformances including liaison with 3rd party sorters
- Review/audit control charts, procedures for correctness and accuracy
- Maintain organized records as per record retention work instructions
- Participate in continuous improvement initiatives and suggestion program
- Supports all plant TS 16949 & ISO initiatives and requirements
- Review suspect material from your shift’s production supported by Team Leader/Supervisors and enter scrap quantities in T4M after disposition. (Scrap, non-conformances, etc.)
- Champion the quarantine area and its inventory accuracy on a daily basis
- Other duties as assigned by the Quality Manager
- Observe standards for safe working conditions as outlined in the Occupational Health & Safety Act, as well as the rules and regulations outlined in the Employee Handbook
- College graduate in the field of quality or mechanical engineering or equivalent experience
- Must have two years experience in precision machining and/or stamped automotive assembly products
- Knowledge of SPC, measuring equipment, blueprint reading GD&T, filing system (electronic & paper) and TS procedures
- Knowledge of CMM measurements and sedimentation testing’s
- Excellent documentation & organizational skills
- Computer literate (Microsoft Office)
- Ability to demonstrate leadership and train operators to support their operations
- Working knowledge of English language (both written and spoken) able to communicate with internal & external suppliers
- Must be flexible when it comes to working alternate shifts
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Home-based Clinical Quality Assurance Auditor Resume Examples & Samples
- Create, maintain, and revise departmental standard operating procedures, forms, and templates
- Host audits by sponsors and regulatory inspectors
- Coordinate, conduct, and track company-wide regulatory training (ICH/GCP and medical device)
- Work with outside clients/sponsors; and
- Casual dress code
- 24-hour onsite fitness center with a variety of fitness classes; and
- Onsite cafeteria with complimentary lunch daily
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Clinical Quality Assurance Auditor Resume Examples & Samples
- Coordinate and conduct internal system audits and external investigative site/vendor audits
- Develop training materials and applicable tests and guides
- Other items as deemed necessary
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Quality Assurance Auditor Resume Examples & Samples
- Ability to thrive and enjoy working in a fast paced, high performing, customer centric environment
- Proficient in Microsoft Word, Excel and Outlook
- Ability to manage own time efficiently, focusing on the things that are important
- Consistently able to meet deadlines and anticipates any problems
- The ability to interact with others in a positive, supportive way whilst taking into account and respecting the opinions of others
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Quality Assurance Auditor Resume Examples & Samples
- Daily production checking and ensuring procedures are complied
- Prepare and Assist for an internal and external audits such as ISO
- Assist in investigation/ analysis of any quality issue in production and packing
- Conduct internal training (manufacturing training) for staff
- Conduct 5S audit in production and packing area
- Ensuring verification of daily QC functional checks are carried out diligently
- Preparing reports of non-compliance findings (i.e not conforming to process or quality standards)
- Performing other duties assigned by the superior from time to time
- Participate in and support team in all HSE, security, and 5S, Housekeeping policies and procedures. Report all unsafe acts and conditions and security violations. Participate in all scheduled HSE and security trainings
- Other duties as necessary to maintain SLA and other specified department/plant objectives
- The job holder shall at all times during the employment with the company, respect and comply with the Gemalto Quality, Health, Safety, Environmental & Security requirements during the performance of his/her duties
- At least 1 year working experience in manufacturing related field, experience in quality inspection and knowledge in quality process control
- Working in printing industry will be an added adventure
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Quality Assurance Auditor Resume Examples & Samples
- Experience working in a Call Center
- Experience in Microsoft Office suite of applications including Excel (formatting formulas, managing data, and filtering results), Word (creating and editing documents), PowerPoint (creating and editing presentations)
- ICD10 certification
- Experience working with confidential information
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Quality Assurance Auditor Resume Examples & Samples
- Conduct compliance audits to ensure members’ accounts are accurately handled with the plan level selected. This includes the appropriate handling of terminations, binder, and ongoing premium payments being posted timely and accurately
- Record/track quality assessment scores and provide feedback to reduce errors and improve processes and performance to ensure the quality of the network
- Provide suggestions and recommendations on improving controls to gain efficiency and strengthening of compliance measures
- Present results of investigations to senior staff and prepare written reports concerning investigation activities
- Identify defects and improve departmental performance by supporting quality, operational efficiency and production goals
- Assist in the development of departmental policies and procedures; review the efficiency of existing training
- Meet established time frames and rates of performance for the quality and quantity of work for the position
- Experience with auditing billing and accounting
- Experience handling confidential information
