Associate Quality Assurance Associate Resume Samples

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C Cartwright
1784 Rath Fort
+1 (555) 934 9127
1784 Rath Fort
p +1 (555) 934 9127
Experience Experience
03/2015 present
San Francisco, CA
Associate Director Bioresearch Quality Assurance
San Francisco, CA
Associate Director Bioresearch Quality Assurance
03/2015 present
San Francisco, CA
Associate Director Bioresearch Quality Assurance
03/2015 present
  • Liaison with the Quality Management organization within BRQC to ensure the proper role specific curriculums and training records are maintained
  • Project & Audit Schedule Management
  • Development & Maintenance of BRQA Metrics
  • Prepares routine updates for QA LT and as requested for BRQC Janssen SLT or other management venues on the metrics being tracked
  • Periodically reviews the output from each of the BRQA domains to evaluate areas for improved alignment and/or consistency
  • Consistency Across BRQA Domains
  • Supports the QA LT in communication of information to ensure a single message is communicated and applied
06/2010 10/2014
Houston, TX
Cao-kyc Quality Assurance Senior Associate
Houston, TX
Cao-kyc Quality Assurance Senior Associate
06/2010 10/2014
Houston, TX
Cao-kyc Quality Assurance Senior Associate
06/2010 10/2014
  • Perform root cause analysis and make recommendations for addressing identified deficiencies or improvements to business processes
  • Work with Global Partners to ensure consistency with the Global QA framework and governance approach
  • Perform ongoing formal testing of completed work cases to ensure controls / standards are met
  • Manage team KPIs (key performance indicators) to ensure consistency in quality and timeliness of completion
  • Working knowledge of MS office & MS SharePoint
  • Review of all discrepancies or newly discovered trends with QA Managers in CAO for proper disposition and potential amendment to procedure
  • Identify key issues, risks, trends, observations and provide reporting of results to key stakeholders
09/2005 01/2010
Phoenix, AZ
Quality Assurance QAR Associate
Phoenix, AZ
Quality Assurance QAR Associate
09/2005 01/2010
Phoenix, AZ
Quality Assurance QAR Associate
09/2005 01/2010
  • Conduct quality-related reviews of agent performance, evaluating against client and internal quality standards to ensure proper call and transaction handling. This includes call monitoring, review of data entry/transactions processed, and evaluation of any other performance metric that may impact quality (i.e. handle time, speed of answer, etc.)
  • Provide value added feedback to Quality Manager and Supervisors on how to improve call handling and increase knowledge of process and procedures to drive quality improvement
  • May participate in and support the Quality Management (QM) Program in identifying and acting on opportunities that improve the quality and value of the service we provide to our clients and our employees
  • Perform other duties as assigned by management
  • Provides feedback reports on call issues related to downtime and/or training issues
  • Makes attempts to resolve issues and deescalate issues of irate or dissatisfied clients
  • Research all aspects of projects & processes to make solid and substantiated recommendations back to the business
Education Education
Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Life Sciences
Tulane University
Bachelor’s Degree in Life Sciences
Skills Skills
  • Knowledge of EPA, FDA, and OECD Good Laboratory Practice (GLP) regulations and commonly used concepts, practices, and procedures within GLP QA field
  • Detail-oriented and highly organized
  • Excellent interpersonal skills
  • Ability to effectively prioritize workload and manage changes in direction
  • Computer skills: working knowledge of Internet, MS Word, Excel, Outlook, SharePoint and PowerPoint
  • Ability to multitask and work under pressure of multiple projects and deadlines
  • Effective oral and written communication skills
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Quality Assurance Test Lead-associate Resume Examples & Samples

  • Working with a number of key teams including, Project Managers, Architecture and AD to produce non functional test approach and execution plan
  • Working with the BA’s and architecture team, producing and designing test plans and test cases to ensure performance requirements are met. This will include analysis of complex system flows and data profiling to ensure execution is performed with production like profile at projected peaks
  • Manage the execution team and plan providing stewardship and expert guidance to the team throughout the planning and execution stage
  • Analyse performance results and develop and document the agent distribution profile for the application and middleware tiers with the AD team
  • As subject matter expert, provide technical guidance to the non functional team to ensure test cases are appropriately detailed and are scheduled in an efficient manner
  • Managing and maintain iDDA Non Functional test assets, including configuration management of test plans, data, automation scripts and test results
  • Ensure defects are raised, recorded with quality and managed to resolution
  • Produce regular status reports and articulate status to key stakeholders within the technical and business communities
  • Track systemconfiguration changes with the ADInfrastructure teams that have passed testing, ensuring that they are promoted form test environment to production
  • Working with the QA Non Functional Test Lead, leverage existing tools to automate non functional test case execution, including results capture and analysis
  • The candidate must have a proven track record in technical testing complex distributed applications. This must include exposure to technical testing real time message based applications with a middleware layer
  • The candidate must also been exposed to resilience testing on distributed applications for each tier in the distributed stack. This includes application tier (Unixjava), database tier (UnixOracle RAC), Middleware Tier (SolarisWebMethodsMQ), Web Tier (Weblogicjsp)
  • Knowledge of clustering technologies such as VCS or similar would also be essential
  • The ideal candidate would be an established thought leader in Non Functional Testing who is committed to the testing discipline and has previous experience of working in other technology functions such as AD, Networks, System Admin on SolarisUnixJavaWebMethods and Oracle technology stack
  • Excellent analytical skills and can demonstrate proven track record in performance testing and tuning distributed applications
  • Capable of analysing complex requirements and design specifications and design test cases to prove specifications
  • Excellent technical understanding of Linux process architecture and inbuilt performance monitoring tools
  • Excellent understanding of clustering technologies and recovery models for distributed applications
  • Extensive experience in using performance profiling tools such as jconsoleWiley or equivalent
  • Experience of data profiling and modelling data to meet performance requirements
  • Excellent understanding of main components in Oracle RAC or equivalent database clustering technology
  • Experience of interpreting and anlysing OEM performance reports
  • Experience of Middleware technologies and concepts
  • Excellent understanding of security technologies applied in mission critical distributed environments
  • Good working knowledge of network technologies and protocols such tcpip
  • Experience of managing on and off shore resources in testing discipline
  • Experience of using integration test tools such as Greenhat or equivalent
  • ISEB Testing foundation level qualified or above
  • Experience using Quality Centre (Mercury Test Director) or equivalent test management tool
  • Experience of performance testing web based applications
  • Experience of testing enterprise monitoring solutions such as TivoliBAM
  • Experience of using esting batch schedulers such as Autosys
  • Familiar with backup and recovery technologies for large sized databases

Transaction Quality Assurance Senior Associate Life\annuity Claims Focus Resume Examples & Samples

  • Incumbents of this job will have the end to end responsibility for ensuring all transactions being processed meet the guidelines and client metrics set in terms of transaction quality and errors. Transaction to be scored will include both recorded customer service phone conversations, and also all types of system transactions
  • The employee will be responsible for performing audits on transactions based on predefined audit parameters. Classify errors based on the type of the error, perform root cause analysis, and can assign root causes for errors
  • Accurately reports the required data for Projects/Initiatives
  • Ability to perform audit and report the findings to improve quality performance of the team

Accounting Quality Assurance & Risk Team Associate Resume Examples & Samples

  • Monthly Final Accounting Review of NAVs completed in other MSFS locations within a defined time delivery schedule
  • Spearhead Quality Assurance and Risk Management initiatives and projects within Accounting with a drive towards ensuring consistent high quality work products are delivered
  • Assist in the development of best practices for Fund Accounting to enable the firm to improve its efficiency and effectiveness while ensuring that the firm is producing quality output
  • Build and manage relationships with senior management and other business owners to champion deliverables
  • Integrate with global colleagues to ensure standard operating practice
  • Influence, motivate and develop team members in areas of responsibility in order to maximise their contribution to the team, organisation and their own professional development
  • Bachelor’s Degree in Accounting
  • Fully completed Accounting qualification/certification e.g. CPA, CA, ACCA, CIMA,
  • Minimum 5 years PQE with public accounting experience servicing investment related companies preferred. Ideal candidate should demonstrate extensive experience in auditing and a thorough understanding of industry and accounting practices
  • Previous Quality Assurance and/or Risk Management experience in a related field would be an advantage
  • Dynamic leader and proven team player

Accounting Quality Assurance & Review Team Associate Resume Examples & Samples

  • Spearhead Quality Assurance initiatives and projects within Accounting with a drive towards ensuring consistent high quality work products are delivered
  • Maintain up to date knowledge of GAAP and industry updates and ensure relevant application of the same
  • Influence, motivate and develop team members in areas of responsibility in order to maximize their contribution to the team, organization and their own professional development
  • Undertake any other responsibilities, tasks or activities as reasonably required
  • Fully completed Accounting qualification/certification e.g. CA, ACCA, CIMA, CPA
  • Experience in the Hedge Funds industry is required. Public accounting, Hedge Fund Administration or management experience is a distinct advantage
  • Strong technical skills. US GAAP & IFRS knowledge required including strong understanding of hedge fund structures
  • Excellent interpersonal skills, both oral and written
  • Ability to think strategically with excellent planning and prioritisation skills
  • Strong work ethic and ability to be flexible and be involved in ad hoc projects as and when they arise

Associate Embedded Software Developer Quality Assurance Resume Examples & Samples

  • Develop C/C++ unit and integration tests to validate driver and kernel-level software for Ford’s SYNC infotainment system
  • Test embedded OS on Ford SYNC hardware: bootloader, kernel, drivers, build environment, and upgrade system
  • Manage hardware variation by creating tests to ensure a common platform for existing and future hardware
  • Participate in bring-up and validation of new hardware and boot-up performance optimization
  • Participate root cause analysis of hardware quality problems and software defects
  • 2+ years C/C++ software development experience on embedded, mobile, or consumer electronic platforms
  • Proficiency of C/C++ language, GNU toolchain, and Unix: QNX, Linux, or equivalent
  • Experience with embedded build systems including: QNX system builder, buildroot, open embedded, or equivalent
  • Experience developing programmable digital logic including: FPGA / CPLD design using VHDL, Verilog, or equivalent
  • Proficiency with revision control including: git, subversion, or equivalent
  • Working knowledge and experience developing an infotainment feature technology, such as navigation, voice recognition, media phone, or a similar technology

Senior Associate, AML Quality Assurance Resume Examples & Samples

  • 3-5 years BSA, AML, OFAC, KYC or similar industry experience required
  • Strong knowledge of Suspicious Activity Reporting (SAR) investigation and process
  • Leadership/coaching experience required
  • Intermediate or above experience in Microsoft Office applications required
  • Critical thinking, process improvement mindset
  • CAMS or similar Certification preferred, or the qualifications to become certified within one-year of hire
  • Accuity Compliance Link and Actimize experience preferred

Enhanced Quality Assurance Testing Associate Resume Examples & Samples

  • Maintain high level of compliance awareness and knowledge
  • Review, research, troubleshoot and document (reporting, data analytics, handling escalation scenarios, policy and procedure reviews and updates)
  • Communication and relationship building with internal stakeholders, (reporting, escalation, create and enhance test scripts)
  • Provide process improvement proposals to reduce risk of control failure and drive process efficiencies
  • Thorough knowledge of federal regulatory consumer laws and regulations, specifically the, with a particular emphasis on Flood Disaster Protection Act and Briggert-Waters Flood Insurance Reform Act of 2012
  • Understanding of auditing, quality assurance and quality control programs within a financial services environment
  • Ability to work independently, with minimal guidance, and successfully meet deadlines

Quality Assurance Compliance Associate Resume Examples & Samples

  • Provide quality reviews of documentation and determine subsequent duty of care dis-position of goods to the Sandoz US Distribution Center
  • Verify Transportation conditions of incoming materials
  • Acts as a control checkpoint for final release authorization
  • Identifies deviations from established standards in the transport and storage of goods
  • Initiate deviation records for issues that arise at the Sandoz US Distribution Center
  • Can undertake root cause analysis with supervision
  • Serves as a liaison between the Sandoz US Distribution Center and the Sandoz sites to assure rapid response to quality matters and minor issue resolution
  • Provide first level of response for Quality and Compliance issues noted at the Sandoz US Distribution Center and escalate as required
  • Interactions with other departments to resolve documentation issues
  • Participates in products launches as needed
  • Adheres to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements (For example: OSHA, DEA, FDA, ect.)
  • Professionally interacts with Sandoz sites and Sandoz US Corporate departments as required
  • To perform this job successfully, an individual must be able to perform each essential duty satisfactorily
  • The requirements listed below are representative of the knowledge, skill, and/ or ability required
  • Individual must meet all requirements as outlined in the Novartis Core Values and Behaviors
  • Refer to annual performance target setting

Associate Director, GLP Quality Assurance Resume Examples & Samples

  • Demonstrates strong aptitude for facilitating group or project team endeavors, and building team unity
  • Demonstrates strong ability to effectively communicate and influence the outcomes of the decision making process
  • Displays highly developed organizational leadership qualities
  • Proven ability to manage projects/teams of moderate scope and complexity, while meeting all deliverables and timelines
  • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to GLP quality systems and management
  • Participates in developing department goals and ensure linkage to individual goals
  • Displays highly effective coaching abilities as well as a successful track record of developing junior staff
  • Conduct presentations on quality issues, initiatives and projects at cross functional meetings
  • Reports directly to the CQA Sr Director GCP/GLP/GPP
  • Development, implementation, and oversight of quality activities in support of GLP activities conducted or monitored by Vertex Pharmaceuticals Inc
  • These activities focus around the qualification and monitoring of GLP Vendors and performing duties required of an Internal Quality Assurance Unit
  • Collaborates with internal departments on strategy and implementation of quality principles and regulation requirements
  • Core member of the GLP-Quality Leadership Team
  • Provides Quality insight/feedback to internal departments. This may come in the form of SOP reviews and/or ad-hoc requests
  • Development and reporting of compliance metrics related to GLP activities
  • Coaches/mentors staff as a means to ensure performance and professional development
  • Establishes/maintains effective cross functional team communications to advance quality activities of Vertex
  • M.S. in a scientific or allied health field and 10+ years of relevant CQA-GLP work experience, or
  • B.S. in a scientific or allied health field and 12+ years of relevant CQA-GLP work experience, or relevant comparable background
  • 5+ years’ experience serving in a Quality Management role
  • This position requires up to 10%-20% travel
  • GCP experience is an preferred asset
  • Has an excellent understanding of operational GLP’s
  • Managerial experience in planning and personnel development is required
  • Demonstrated leadership skills are critical to this role
  • Proficiency in using Microsoft Office applications required (MS Word, MS Excel, Trackwise, MS PowerPoint, Viso, and Trackwise)

Master Associate, Plant Quality Assurance Resume Examples & Samples

  • Responsible for executing Plant QA operations required to assess, evaluate, and review operations on the floor (as defined above) against cGMPs and to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to MFG, E&T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business
  • Performs independent technical review of documentation during and post-execution of cGMP activities including executed batch records, work orders, SOPs, Job Plans, and other documentation requiring Plant QA final approval. Ensures all specifications are met and that applicable requirements are completed and acceptable. Ensures all issues/documentation associated with each process in assigned area have been resolved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings internally and to appropriate departments
  • Provides continuous improvement ideas within Plant QA and other areas supported by Plant QA to recognize opportunities for improvement and drive change through the use of BIFI's Quality Systems. May attend project team meetings to provide Plant QA guidance and oversight to such improvements
  • May be asked to serve as a Subject Matter Expert for internal matters such as batch record review or electronic batch record approval. Participates in inspection readiness activities and is involved in inspections by regulatory agencies

Associate Director of Quality Assurance Resume Examples & Samples

  • Adapts departmental plans and priorities to address business and operational challenges
  • Product, service or process decisions are most likely to impact multiple groups of employees and / or customers (internal or external)
  • 5+ years of experience with Quality auditing and management experience
  • 5+ years of people leadership experience with a team of 10 or more direct reports
  • Bachelor’s degree or related work experience
  • Formal Quality Training with Certification (Six Sigma, Lean)

Associate Director Bioresearch Quality Assurance Resume Examples & Samples

  • BRQA SOPs and Job Aides
  • Supports development of Standard Operating Procedures (SOPs) and Job Aides as a or with the assigned Process Owner to reflect the practices of the BRQA organization
  • Ensures the cyclical review of all BRQA SOPs/Job Aides as per the Enterprise Standards
  • Liaison with the Quality Management organization within BRQC to ensure the proper role specific curriculums and training records are maintained
  • Liaison with the Quality Management organization within BRQC to develop applicable training materials for new or revisions to SOPs/Job Aides
  • Serves as backup for auditors during periods of high workload or unforeseen circumstances to ensure business continuity. May lead and manage the planning, conduct and reporting of BRQA audits of activities, data, internal and external facilities and processes in GxP/non-regulated areas to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. This includes for cause, complex and business critical audits
  • Consistency Across BRQA Domains
  • Works with the four (4) Domain Heads and their respective Team Leads in ensuring robust communication and documentation exists between the different teams to ensure consistency in practices throughout BRQA
  • Supports the QA LT in communication of information to ensure a single message is communicated and applied
  • Periodically reviews the output from each of the BRQA domains to evaluate areas for improved alignment and/or consistency
  • Development & Maintenance of BRQA Metrics
  • Liaison with the Analytics department to support the development and maintenance of BRQA metrics to ensure that the organization is in compliance with applicable Enterprise Standards, Corporate Policies, SOPs and Job Aides
  • Prepares routine updates for QA LT and as requested for BRQC Janssen SLT or other management venues on the metrics being tracked
  • Facilitates QA LT discussions related to analysis of metrics and determining actions required to improve and/or maintain metrics
  • Status & Fulfillment of BRQA Goals & Objectives
  • Develops a scorecard to enable QA LT tracking of compliance against agreed G&Os
  • Facilitates QA LT ongoing review of BRQA G&Os to ensure on-time completion and where applicable, ensures mitigations are discussed to get an off-target G&O back in alignment with expected timelines
  • Ensures alignment between QA LT agendas and BRQC Pharma SLT agendas such that relevant updates can be provided when required
  • Tracks the action items coming out the QA LT meetings and facilitates review during consecutive meetings
  • Project & Audit Schedule Management
  • Takes an active role in, and leads, projects and teams in key project initiatives across the organization or company. Influences stakeholders and determines priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress
  • Facilitates the cross-domain audit schedule compilation, maintenance of change list and approval/issuance of monthly updates and posting on the BRQC portal
  • Supports the resource allocation of auditors when cross-domain resources are necessary
  • Stakeholder Feedback
  • Periodically analyzes stakeholder / business partner feedback and reviews outcome with QA LT
  • Auditor / Subject Matter Expert / Point of Contact
  • Maintains expert level GxP knowledge in at least one regulated discipline (AWP/GLP/GCP/GCLP/Non Regulated/PV/QMS/IT)* with the ability to provide critical information, advice and guidance on complex quality and compliance issues
  • Proactively identifies the need for and leads information sharing initiatives. Interprets and applies regulations and policies to unique and complex issues in order to influence decisions and actions. Independently provides strategic advice to internal or external stakeholders to drive policy and decision making
  • May serve as a primary contact for internal and external stakeholders and represent BRQA in an expert capacity. Communicates internally to ensure a departmental unified position regarding advice and consultation is provided
  • Learning & Collaboration
  • Mentors and facilitates successful overall BRQA team behavior, providing a strategic perspective to drive the BRQA team toward successful outcomes that are in alignment with departmental goals and objectives
  • Establishes collaborative partnerships with business partners and colleagues, navigating sensitive relationships and tasks with appropriate diplomacy in order to obtain feedback on audit conduct and reporting
  • Proactively liaises with business partners and across segments providing tactical compliance support and consultation as supported by skill set(s)
  • Degree of Supervision, Autonomy
  • Innovation
  • Thorough knowledge of the drug development process
  • Expertise in one or more specific compliance disciplines (AWP/GLP/GCP/GCLP/Non Regulated/PV/IT/QMS)
  • Prior pharmaceutical and quality/compliance related experience
  • Knowledge of auditing techniques is preferred
  • Fluent written and spoken English is required
  • Strategic thinking and quality mindset

Senior Associate, AML Quality Assurance Resume Examples & Samples

  • Engaging the relevant team(s) and management to remediate issues or problems uncovered during quality assurance reviews
  • Previous management experience required
  • Lean/Six Sigma certification preferred

Associate, / III, Quality Assurance Resume Examples & Samples

  • Exceptions, Complaints and CAPA: Assesses criticality of exceptions/investigations for product impact. Performs thorough reviews of the investigations and provides feedback to the department owner. Supports complaint investigations with the ability to analyze the complaint defect and determine potential areas within the process that may have attributed to the defect. Collaborates with associated departments to determine the appropriate CAPA
  • Product Quality Reviews: Manages and tracks the reporting period for each product. Researches and analyzes all product information: released/rejected batches, batch yields, QC release and stability data, exception review and trend analysis, CAPA effectiveness, change control, quality agreements, qualifications of critical equipment, etc
  • Demonstrated understanding of aseptic processing and application of CGMP’s, relevant laws, guidance’s, directives and current industry practices
  • Ability to work and coordinate activities with multiple functional groups with sense of urgency
  • Problem identification and resolution skills

Cao-kyc Quality Assurance Senior Associate Resume Examples & Samples

  • Act as a key liaison with various groups, including GFCC, Corporate KYC Operations and the LOB
  • Act as a resource to team and other stakeholders on AML/KYC due diligence matters
  • Review testing results of QA team to ensure accuracy and completeness
  • Manage team KPIs (key performance indicators) to ensure consistency in quality and timeliness of completion
  • Track and analyze team quality control issues related to testing and guide to resolution accordingly; escalate as appropriate
  • Perform ongoing formal testing of completed work cases to ensure controls / standards are met
  • Identify key issues, risks, trends, observations and provide reporting of results to key stakeholders
  • Perform root cause analysis and make recommendations for addressing identified deficiencies or improvements to business processes
  • Present complex and sensitive issues to senior management in a persuasive manner
  • Review of all discrepancies or newly discovered trends with QA Managers in CAO for proper disposition and potential amendment to procedure
  • 7+ years of experience with Financial Services industry, AML/BSA, KYC, Sanctions, Compliance, Investigative or Quality Assurance background preferred
  • Strong knowledge of JPMC KYC standards, guidelines, policies and procedures and due diligence requirements across all regions
  • Proven ability identifying issues/defects and recommending solutions

Quality Assurance Batch Release Associate Resume Examples & Samples

  • BA/BS degree, preferably in a science related field
  • Minimum five (5) years of progressive quality review and release experience in production facility
  • Experience in FDA regulated environment with knowledge of Good Manufacturing Practices
  • Computer skills required, including Microsoft Word, Excel, PowerPoint and Outlook. SAP experience preferred
  • Excellent interpersonal skills and ability to work with all levels of an organization
  • Ability to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
  • Must be able to work effectively in a team based environment

Quality Assurance Technical Services Associate Resume Examples & Samples

  • 100% - For the first 3-6 months of employment: complete training per training program. Write weekly report of learnings and submit to manager using the Technical Services Associate training guide. Complete HR On-boarding Guide per schedule. Meet with manager to discuss progress at a defined frequency
  • 10-20% - (depending on plant location) Provide back-up assistance for QA Technician roles
  • 4 year degree in Quality Assurance, Microbiology or other related science field
  • Leadership capability
  • Demonstrated ability to multi-task and prioritize work
  • Demonstrated effective communication skills (written, verbal)
  • General computer skills
  • Ability to deal with conflict
  • Must be willing to relocate
  • Must have flexible hours and be willing to work 1st, 2nd and 3rd shifts, and occasional weekends
  • This job involves physical activity which generally requires a moderate amount of exertion on a fairly regular basis – involving bending, stooping, squatting, twisting, reaching, working on irregular surfaces, occasional lifting of objects weighing over 50 pounds and frequent lifting of 10-25 pounds. The work may also involve other exertions, conditions or exposures (i.e.- heat, cold, working in wet environment)
  • Prior experience in a lab setting
  • Familiar with product testing
  • Knowledge of food related bacteria, related to product safety and quality
  • Ability to identify significant changes and trends in data

Associate Tester Quality Assurance Resume Examples & Samples

  • Undergraduate degree Information Technology or business field or equivalent experience/training
  • Proficient in Windows environment and solid skills with Microsoft Office software
  • Ability to effectively meet deadlines in a dynamic and fast-paced work environment
  • Demonstrates initiative, follow-through, and sound business judgment
  • Sound business knowledge of airline field, ramp related operations and applications highly desirable

Quality Assurance Testing & Compliance Associate Resume Examples & Samples

  • Responsible to update, develop, review, analyze, determine and communicate dispositions of testing protocols and report outcome internally and externally
  • Knowledge of government and state legal regulations while maintaining awareness of industry standards to ensure compliance to safety standards while meeting brand aesthetic
  • Work closely with Product Development, Production, Fabric/Trim and Quality Assurance to ensure that all merchandise meets or exceed the brand’s and customers’ quality expectations
  • Analyze return rate data to identify and correct quality at the product level as well as improve vendor performance
  • Responsible for all communication between Lilly Pulitzer® vendor/factories and 3rd party testing facility. Develop and document testing charts and tracking reports to help maintain timing and approvals. Responsible for all payments regarding testing, ensuring invoices are accurate and paid on time
  • Research state and federal regulations and laws as well as industry leading voluntary standards to develop and maintain internal testing programs and protocols
  • Review, validate and analyze test reports to ensure all products adhere to government regulations and are in compliance with US requirements as well as Lilly Pulitzer® standards in all product categories
  • Oversee the compliance program in order to operate fully within the laws instituted by the consumer product safety commission, California proposition 65 and all legal and state requirements
  • Implement, review and refine protocols and testing requirements to ensure Lilly Pulitzer® is meeting and exceeding government regulation and requirements
  • Maintain awareness of industry standards to ensure compliance, while meeting brand aesthetic
  • Ensure all legal documentation for all merchandise is organized, accounted for and properly recorded
  • Be fully knowledgeable on all compliance requirements, federal and state regulations
  • Ensure that proper testing is communicated during the development process so that testing protocols and product quality goals are appropriate and understood internally and externally
  • Manage testing protocols and procedures for corporate and vendor use to ensure specifications with high quality products are met including fabric, trims and garments
  • Communicate effectively with all internal and external parties
  • Explain and clearly communicate test methods as well as standards and requirements to both internal and external groups
  • Maintain awareness of all fabric related technical trends, innovative fibers, new technologies and finishing technique in the textile and apparel industry
  • Collaborate with Fabric, Trim, R&D and Surface Design Departments to ensure that all products are developed to pass all testing protocols
  • Validate all merchandise testing is passing against the TOP
  • Analyze and review data and provide clear direction to both internal and external groups
  • Educate and discuss potential risk, provide collaborative solutions to all internal and external partners, during development and bulk stages of the product
  • This position requires a high level of responsibility, dependability and commitment
  • Strong understanding of FTC and Legal regulations
  • A solid background in product testing and implementing testing protocols
  • The ability to act as liaison between many departments
  • Possess strong written and verbal communication skills to deal with various levels of management and employees internally as well as vendors/factories
  • Analytical skills
  • High level of Urgency
  • Strong understanding of FTC rules on care labeling
  • Strong understanding of testing protocols and industry standards for 3rd party testing facility
  • The ability to make judgements and risk assessments based on tests and fabric and trim specifications
  • Knowledge of pattern making, fabric inspection, and sewing experience is helpful
  • Ability to collaborate with cross functional teams to influence and gain desired out comes
  • Bachelor’s degree in Fashion Merchandising, Apparel Production, Product development, Textile Management, Product safety
  • 1-3 years’ experience in Quality Assurance/compliance
  • Basic Understanding of Government Regulations
  • Understanding on how to evaluate products to company standards
  • Knowledge of fabric and garment testing for both apparel and non-apparel items

Associate VP-head of Quality Assurance Resume Examples & Samples

  • Experience from Quality Assurance of systems with high requirements on availability and reliability
  • Experience from multiple disciplines within Quality Assurance
  • Experience from Test Management in large scale projects
  • Experience of being a manager of managers or at least managing larger teams
  • Good understanding of how to effectively work with distributed teams
  • Understanding of both agile and traditional development environments
  • Ability to adapt to changing circumstances
  • Takes the lead on process improvement for any Nasdaq large project oriented re-engineering efforts globally
  • Analyzes and measures the effectiveness of existing business processes and develops sustainable and quantifiable business process improvements which impact the business globally
  • Collects and analyzes process data to make recommendations on improved business practices and procedures and drives sustainable change across Nasdaq
  • Determines how new information technologies can support reengineering business processes and influences global thinking on NASDAQ business processes
  • Provides leadership and direction through team members
  • Oversees the performance and results of diverse teams, disciplines, or departments
  • Executes the organizational strategy set by top management, clarifying expectations for team members
  • Develops and oversees the execution of functional/departmental strategy to achieve key business/organizational objectives
  • Oversees and at times manages the development and execution of functional projects
  • Serves as the primary contact for leadership, internally and externally and leads the vendor selection process for business unit and/or organizational initiatives
  • Interacts regularly with top management to communicate status and provide reports on the performance of the business unit/function
  • Drives cost-savings and risk mitigation strategies and reviews business unit or function’s performance data (financial, sales, activity reports, etc. to monitor and measure productivity, goal progress and activity levels)
  • Assists in growing the organization globally through awareness and application of global trends and markets in one’s business unit
  • Coaches and inspires lower level managers to achieve better performance
  • Motivates, develops, recruits and retains employees while rewarding and cultivating a culture of high performing teams
  • Requires broad and comprehensive understanding of different systems, theories and practices as well as the changing business environment
  • Applies in-depth knowledge of own function, business and commercial expertise to differentiate itself from the competition
  • Leads a function typically through multiple teams and projects with diverse activities; develops and executes functional strategy to achieve key business objectives
  • Evaluates key business challenges; directs the development of new or innovative solutions
  • Guided by company strategy and functional business objectives, impacts results of a core business
  • Influences and negotiates with great latitude on outcomes; presents and defends complicated or delicate issues
  • Inspires others by communicating the vision of the organization and describing individual opportunities
  • Communicates personal investment in the organization and its success to demonstrate commitment to employees and build the sense that “we are in this together”
  • Ensures that employee engagement is measured regularly within the business unit/function and implements appropriate measures to sustain engagement
  • Shapes developmental roles and assignments to balance individual and business unit/function needs
  • Provides in depth, one-on-one feedback and/or coaching to enable direct reports to achieve performance goals and maximize their potential
  • Makes selection decisions with the organization’s overall talent management strategy in mind
  • Encourages leaders to balance strengths and development areas among employees when assigning talent, ensuring a diverse distribution of necessary skills to meet the business unit/function’s goals
  • Demonstrates understanding of ongoing and future talent needs and looks for ways to address those needs through effective recruitment and development of talent
  • Recommends initiatives that strengthen and align talent development with future needs of the business unit/function; provides input for succession planning
  • Uses knowledge of the business model, and challenges assumptions and conventional thinking to develop new strategies for the business unit or function
  • Communicates the organization’s vision to the business unit/function to gain support and motivate others and build a sense of shared purpose
  • Identifies criteria to assess strategic alignment and success of plans tracking against measurable business unit/function success factors
  • Seeks to understand the main business drivers of current and potential customers, and designs solutions accordingly
  • Creates and supports programs that improve the business unit/function’s reputation for providing excellent customer service; understands the external factors that may impact a customer’s perspective
  • Anticipates emerging trends that will impact future customer needs and prepares the business unit/function to respond
  • Frequently communicates the business necessity and benefits of change to employees
  • Translates change initiatives into tactics and operating plans for the business unit/function
  • Identifies and anticipates potential concerns for key stakeholders and uses multiple strategies and methods to gain support for change

Associate Director West Point Quality Assurance Resume Examples & Samples

  • Automation Compliance team - This team is responsible for change control approvals of automation systems, SAP and MES. In addition, the Lead will help support enhancements to the Site Data Integrity procedures and processes. The role will require the oversight of ~6 direct reports
  • Change Control team - This team is the primary quality contact for change control administration at the site. In addition, the Lead will help support enhancements Quality System Improvement Program (QSIP) and help to integrate all change control into a single focused Quality Assurance function. The role will require the oversight of ~8 direct reports
  • Supplier Management/Annual Product Report team - This team is tasked with completion of the APRs, Quality Agreements, Business Continuation Memos and various other Supplier Oversight functions for the West Point Site. The role will require the oversight of ~7 direct reports
  • Quality Systems knowledge
  • Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc
  • Technical understanding of Biologics, vaccines and small molecules business
  • Understanding of Merck’s Quality System

Associate Director Site Quality Assurance Resume Examples & Samples

  • Management of the Internal Inspection Programme and Management of the External Inspection Programme (and, in conjunction with the Divisional auditing group, inspection management of raw material/ component, contract Laboratories & Manufacturers and GMP suppliers). Will also provide oversight for the training and coaching of internal auditors to drive QMS holistic reviews and continuous improvement initiatives
  • Participate and Comply with the Quality Management System (QMS) requirements, including ownership, as relevant to you
  • Co-ordination of inspections by Divisional Auditing Group and Regulatory Bodies
  • Review & approval of GMP procedures and associated documents
  • Continuous improvement of systems & procedures on site, to ensure compliance with the most up to date cGMPs
  • Drive the implementation of integrated Quality Risk Management at the site
  • Manage generation & review of quality compliance metrics and provide appropriate governance through functional unit team review and monthly Site Quality Council (SQC) reviews
  • Provide oversight and coaching for the Quality aspects of Supplier Management
  • Manage Quality Management System (QMS) core requirements, policies, procedures & guidelines compliance
  • Provide Quality support to engineering commissioning, system qualification & process validation projects & schedules. Support to include providing quality input into validation project approach, protocol & report review and approvals
  • Co-ordination of the area resources to deliver a quality and efficient support service & development of area personnel and provision for succession & delivery of area performance to meet or exceed performance and quality goals
  • Control of area expenditure within budgetary limits & contribute to site management operational and strategic initiatives
  • Responsible for driving a culture of Continuous Improvement by deploying MSD Six Sigma tools within the CoE Group on projects such as: Problem Solving, reducing cycle time, Lean principles within the process
  • Develop an effective, focused and strong CoE team by understanding each person's abilities, unique contribution and broadening their skill set to be agile and prepared for any future business requirements
  • Provide the team with the tools and development opportunities (including educational assistance, job rotation, cross-functional training, Six Sigma)
  • Degree or 3rd level qualification (Science, Quality)
  • QP qualification (Desirable)
  • Evidence of Continuous Professional Development
  • Preference for at least a Lean Six Sigma Green Belt
  • Proven track record of delivering high performance through development and coaching of a team
  • Process and technology background: the successful candidate will fully understand how to drive optimization, OEE and commissioning
  • Demonstrated ability in holding team members accountable for results and managing performance
  • Demonstrated ability to fully realize improvement initiatives
  • Demonstrated successes in a team environment, such as project teams, Lean Six Sigma team, PITs etc
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.)
  • At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality function
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies
  • Knowledge and experience in interpreting current regulatory requirements and providing independent support to a manufacturing operation
  • Demonstrated leadership and change management skills with a continuous improvement focus

Transaction Quality Assurance Senior Associate Resume Examples & Samples

  • Monitor and grade recorded interactions versus department standards using applicable quality monitoring system (currently Avaya WFO)
  • Provide detailed feedback on the interactions in reports to front line staff, team leaders, supervisors and PSC Manager
  • Help drive culture of continuous improvement by always providing positive, as well as developmental feedback to team members in any coaching interaction in which they participate
  • Quality average should be 93 or over
  • Ability to coach staff consistently

Quality Assurance QAR Associate Resume Examples & Samples

  • Participate in internal and external client monitoring/calibration sessions in order to ensure thorough understanding of programs, goals and client standards of excellence
  • 1 year experience in a call center environment required
  • Demonstrated ability to meet client requirements based on recent, consistent call quality scores at meets or exceeds level

Associate Director West Point Quality Assurance Resume Examples & Samples

  • · Quality Systems knowledge
  • · Exposed to application of Risk Management tools and methodologies such as: FMEA, PHA, Risk Rank and Filtering, Risk reporting, etc
  • · Ability to accurately interpret and apply regulatory expectations to the Quality Management System in a drug, device and biologics manufacturing environment
  • · Fast learner and can be a change agent
  • · Technical understanding of Biologics, vaccines and small molecules business
  • · Understanding of Merck’s Quality System
  • · On the floor manufacturing shop experience

Associate Director of Quality Assurance HPV Resume Examples & Samples

  • Candidate should have worked previously in QA/Product Release or in Technical Operations. Candidate should have experience with regulatory inspections
  • Previous management experience
  • Candidate should have worked 5+ years in QA/Product Release w/ experience? Preferred submitting CBER protocols or 5+ years in Technical Operations? Preferred supporting manufacture of vaccines in classified (C space)
  • Candidate should have experience with regulatory inspections (FDA and international). Experienced with Deviation Management, CAPA and Change Control Systems
  • Excellent communication and decision making skills

Associate, or, Quality Assurance Resume Examples & Samples

  • Review and approval of batch related documentation (cGMP procedures, Master Production Records, Solution Lot records, protocols and reports) to support product disposition
  • Executes activities including; intermediate technical writing, intermediate investigation support (root cause analysis/impact assessment), project representation (moderate complexity)
  • Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen
  • LI-SRC6
  • Plans schedules and arranges own activities when accomplishing objectives
  • Must be able to deal with ambiguity and be resourceful
  • General understanding of Quality role and concepts; able to practice and implement them
  • Detail oriented aptitude
  • General understanding of the manufacturing process

Quality Assurance QAR Associate Resume Examples & Samples

  • An Associates Degree (AA) from an accredited university or college; or a High school diploma, GED and 1 years related work experience
  • Experience (2+) years in a call center environment
  • Ability to monitor and record improvements in performance

Associate Director, SOX & Quality Assurance Resume Examples & Samples

  • Accountable for coordinating and managing the global SOX compliance program in an efficient and effective manner. This includes taking into consideration of all current and recent guidance on SOX compliance requirements. Scope includes coordination with the IT Audit team on information technology related controls
  • Perform the annual SOX risk assessment and scoping by collaborating with the appropriate business leaders (i.e. Finance Directors) and coordinating appropriately with the Corporate Controller’s team, other risk functions and external auditors. Work with the market businesses, to validate the assessment annually, or when there is a major business change, to ensure that scope and key controls are sufficient and adequately assessed
  • Collaborate with financial leadership at corporate and markets to ensure that adequate internal controls are designed and documented to comply with SOX 404 and company-wide requirements. Monitor for major changes in business, process and systems to ensure timely updating of controls documentation to mitigate the risks
  • Develop and implement efficient internal control testing audit programs and direct internal control testing across all corporate functions and North America business units to evaluate their operating effectiveness. This may include actual testing of select processes, detailed working paper review, test design, sample size guidance, exception evaluation criteria, retest expectations, and global test opportunities
  • Manage periodic progress reporting on SOX compliance efforts including status of open control deficiencies (from internal audits, business controls function testing or assessments, external audits, etc.). Monitor remediation of internal control deficiencies with the appropriate process owners to ensure that issues are brought to logical closure. Help escalate when deficiencies are not remediated timely
  • Identify and evaluate issues and processes that may impact multiple business units. Advise on ideas and solutions that may lead to standardized and improved processes across multiple business units
  • Help coordinate the certification, sub-certification, and representation letter processes on a quarterly and annual basis. Participate in the technical accounting network to share control perspective
  • Optimize available collective resources to avoid duplicate efforts. Resources are available from internal audit, outsourced providers (for example, the Financial Shared Services and Information Technology), and other internal finance functions (guest auditors), etc
  • Assist with establishment of training programs as it relates to SOX compliance
  • Stay abreast of changes to and best practices in SOX compliance and business controls overall. Bring such perspective to MJN to continuously improve our compliance effort
  • Participate in other company initiatives/projects including due diligence, compliance plans, investigations, etc. as needed
  • 7 to 10+ years for prior business experience, preferably with Big 4 or Regional public accounting firms or with the internal audit/ controls department in a U.S. publicly traded, multi-national organization. Has practical experience in delineate between SOX and non-SOX controls and objectives. Has exposure and appreciation for diverse international cultures and customs. Experience managing or directing individuals in remote locations preferred

Associate Tester Quality Assurance Resume Examples & Samples

  • Degree (Bachelor’s) in computer science, computer engineering or relevant work experience
  • 4 - 6+ years software testing/QA experience
  • Agile experience a must
  • Change agility, good verbal and written communication skills, detail oriented
  • Demonstrates initiative, follow-through, sound business judgment

Associate Tester Quality Assurance Resume Examples & Samples

  • Collaborate with overall team to develop test plans
  • Develop testable requirements for user stories
  • Write and execute exploratory test plans
  • Provide frequent feedback on test results and test environmental issues
  • Collaborate with third party vendors and Ancillary Product team
  • Identify system defects, troubleshoot issues and ensure resolution
  • Experience using MS office suite or similar tools
  • Experience in testing web applications
  • Effective communication to others (developer, product owner, and business analyst)
  • Analyze test data results
  • Logical reasoning skills
  • Problem solving skills
  • Passion for delivering value to the customer
  • Travel Industry Experience
  • Experience testing web services & XML
  • 2-4 years QA experience on Scrum or Agile team
  • Degree in computer science, Information System, or equivalent experience

Quality Assurance Call Associate Resume Examples & Samples

  • The Quality Assurance Call Associate I accepts responsibility for monitoring and evaluating customer/dealer call recordings through the use of call monitoring tools
  • Monitor customer/dealer interactions in line with business rules established for Quality Monitoring
  • Consistently and impartially evaluate business processes
  • Properly document findings to ensure proper communication to the end user
  • Notify Quality Assurance Management of identified risks to ensure they are handled in a timely manner
  • Use of appropriate tools to conduct analysis that will ensure processes are in line with business requirements
  • Perform various calculations to ensure accuracy of processes
  • Maintain minimum production standards as identified by Quality Assurance Management
  • Special projects as requested
  • May assist in other related departments as required by business need Qualifications
  • Six (6) months call center experience strongly preferred
  • Microsoft Office and Windows Skills
  • The ability to work well with people from many different disciplines with varying degrees of technical experience
  • The ability to adapt to a dynamic, rapidly changing business and technical environment
  • Strong organization and time management skills with strong attention to detail

Quality Assurance Engineer Associate Resume Examples & Samples

  • Bachelors degree from an accredited college in a related discipline
  • Must be able to obtain a security clearance, but not required to be in place prior to start date
  • Experience working effectively in a matrix management environment
  • Willingness and ability to drive identification of root cause and corrective actions and perform verifications required for any identified non-conformances documented by self or co-workers
  • Ability to interpret drawings, specifications, contracts that will enable development and review of QE processes and related performance metrics
  • Ability to interpret electrical schematics, wiring diagrams, product/performance specifications and other systems integration technical data
  • Good communication skills (written, verbal, and listening)
  • Able to establish good working relationships with internal and external customers
  • The skill and ability to work with varying personalities across all functions/areas
  • The ability to analyze and resolve process issues varying from elementary to very complex
  • Proficient skill level with Microsoft Office applications: Word, Excel, PowerPoint, etc

Associate, or, Quality Assurance Resume Examples & Samples

  • Review and approval of batch related documentation (Master Production Records, Solution Lot records) to support product disposition
  • Review and approval of GMP documents (technical reports, procedures, workflows) to support manufacturing functional areas
  • Aides in implementation of Quality Systems/System Improvements with some guidance, moderate technical problem solving (tools or enterprise systems) within function and across multiple functional areas
  • Supports and/or assists in GxP quality systems-related training. Provides some training within and across functions
  • LI-CTL2
  • Must be resourceful and able to problem solve
  • Detail oriented aptitude and self-sufficient

Associate SHS Quality Assurance Resume Examples & Samples

  • Monitoring and Coaching of all call center agents across multiple teams, products and clients
  • Identify brad and narrow trends of needed improvement within the call center based off of data gathered through QA call monitoring
  • Creates and provides general, standardize and customized training to all employees including new hire, refresher and just in time training on minor enhancements. Functions as a subject matter expert in at least one area of specialty
  • Maintain records, reports and other documentation of quality and phone trends and activities
  • Assist operations management with training needs, coordinating enhancements or needs assessment including independent proactive identification of issues and opportunities
  • Other Call coaching related duties as assigned
  • Conduct Organizational, Performance, and Process Analyses
  • Conduct third internal research/data collection; including, but not limited to: process modeling, gap analysis, focus groups, surveys, and client interviews
  • Collaborate with relevant stakeholders to determine Performance Improvement priorities and develop a strategy for addressing client and corporate needs
  • Partner with appropriate Support Center team members in the design, development, management, execution and monitoring/evaluation of Change Management strategies
  • Lead and manage multiple projects, trainers/resources based on call monitoring trends
  • Create comprehensive communication plans to assist in the roll-out of Corporate initiatives, Change Management efforts, and solution implementation
  • 1+ yr experience with SHS in Reservation Agent Role
  • Must be in good standing
  • Must obtain supervisor’s approval

Quality Assurance Development Associate Resume Examples & Samples

  • In cooperation with local Regulatory Affairs and Patient Safety, keep abreast of regu-latory requirements, and update local management and CPO QA on the possible ramifications of regulatory changes and impact to Clinical Development, MA and PV processes
  • Report monthly Key Quality Indicators (KQIs) related to development activities to CPO QA and monitor them and assure that gaps are addressed appropriately in order to miti-gate risk
  • Conduct ESP (External Service Providers) assessment and/or qualification visits for locally outsourced clinical development, MA and pharmacovigilance (PV) activities. Ensure the ESP selection and management processes are properly followed at the CPO
  • Ensure oversight of POP (Patient Oriented Programs) activities in the CPO and provide guidance to MPOs (Marketing Program Owners) according to current SOP
  • Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Coordinate answers of the auditees, provide guidance in determining country observations root causes and ensure that appropriate corrective and preventive actions are implemented on all major and critical audit find-ings
  • Ensure that deviations and incidents are properly managed in AQWA QE (Quality Event) is and that escalation is performed when required
  • Ensure, where appropriate, interface/communication with authorities for any GCP/PV related activity
  • Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPAs have been completed/closed
  • Together with Local Leadership Team members, ensure conduct of adequate training at the CPO for GCP and GPvP activities by defining, planning and supporting training activi-ties
  • Ensure that the clinical and PV computerized systems are assessed using Risk Assessment for GCP and GPvP relevance to enable their validation where required
  • Support Clinical Operations (ICRO, GMO), MA and Pharmacovigilance associates with quality related issues and provide guidance when necessary
  • Set up quality assessments/self-inspection activities (TMF review, investigator site visits…) in the CPO using a risk-based approach to improve quality of the overseen activities

Associate Tester Quality Assurance Resume Examples & Samples

  • Bachelor degree required
  • Some programming experience in any language
  • Some knowledge of SQL and Unix
  • Proficient in Microsoft Office (Access, Word, PowerPoint, and Excel)
  • Motivated, hard-working individual looking to exceed expectations
  • Organized and able to multi-task
  • Energetic and friendly personality that enjoys working with groups and taking initiative
  • Strong communication and organization skills
  • Eager to learn and encourage peers for continuous improvement, manage priorities, and meet deadlines

Associate Frra Quality Assurance Resume Examples & Samples

  • Assisting in the review of key systems and process flows to identify which elements are critical to downstream reporting
  • Analyzing the source data used in the production of external reporting
  • Assisting in mapping processes and developing corresponding testing strategies
  • Liaising with business contacts to request documentation and to gain clarification
  • Masters / bachelors degree in Accounting / Finance / Business or professional qualifications of CA/CWA
  • 5+ years related experience in Financial reporting or Audit experience
  • Knowledge of US Regulatory and SEC reporting requirements, external reporting control concepts
  • Excellent desktop/spreadsheet/databases and data analytics skills
  • Willingness to work in UK shift & extended UK shift Timings (e.g. upto 12am or 1am)
  • Ability to build and maintain partnerships within the various product aligned business personnel, controller and operations teams
  • Ability to work independently as well as managing a team

Associate Director Pharmacovigilance Quality Assurance Resume Examples & Samples

  • Serve as the Pharmacovigilance Quality Assurance leader in the respective region in the implementation and refinement of processes to ensure that Takeda maintains oversight of the quality of its pharmacovigilance activities in compliance with applicable regulatory requirements
  • Collaborate with the Senior Director, Pharmacovigilance Quality Assurance, to develop and implement the strategy for regional Pharmacovigilance quality oversight to ensure that Takeda meets its sponsor and marketing authorization holder obligations to protect the safety of study subjects and patients
  • In collaboration with R&D Pharmacovigilance Quality Assurance support the development of tactical and strategic audit plans
  • Support the analysis of audit program results, quality issues and investigations in order to identify actionable trends and to promote a state of compliance
  • Serve as a member of the Pharmacovigilance Quality Assurance Leadership team, giving input to key strategic decisions
  • Ensure reports and corrective actions are developed and completed within timelines mandated in Takeda procedures
  • Act as line manager for Pharmacovigilance Quality Assurance in the respective region
  • B.Sc. in Science, Nursing, or related scientific field required. M.Sc. preferred
  • GxP Knowledge: In-depth knowledge of the applicable GxP regulations and ICH Guidelines
  • Pharmacovigilance Development: Understands the phases, processes and techniques used to execute a Pharmacovigilance development program
  • Product Knowledge: Understands the medical/therapeutic impact of products
  • Scientific Knowledge: Possesses the necessary science education and knowledge to manage quality assurance oversight for Pharmacovigilance trials and to assure the ethical treatment of subjects. Understands medical terminology and is familiar with standards of care and disease states
  • Project Management: Must demonstrate proficiency in managing complex projects, delivering all expected deliverables in a timely manner, and proactively communicating changes in pre-established goals and deadlines
  • Must be able to efficiently utilize the computer hardware and software programs provided to plan, manage, conduct and track deliverables and to communicate with internal and external team members

Quality Assurance QAR Associate Resume Examples & Samples

  • Test computers using OBA equipment
  • Document issues
  • Operate and maintain test equipment
  • Document application test plans based on software requirements and technical specifications
  • Ensure compliance with general programming best practices, accepted web standards and those standards set forth by upstream sources
  • Perform QA audits
  • Participate in QA planning meetings
  • Perform walkthroughs in warehouse, looking a quality as a whole
  • Effectively communicate with staff and management
  • Able to pick up on new processes quickly
  • Able to work in a quick repair process, having direct interaction with internal customers
  • Focus on details
  • Vision capabilities to focus on small, intricate parts for extended periods of time

Associate CIB F&BM Quality Assurance Control Team Resume Examples & Samples

  • Leading and participating in QA reviews, including developing testing strategies, executing testing, analyzing results, communicating findings to management, and obtaining corresponding action plans
  • 4+ years related experience
  • Ability to Challenge the status quo while maintaining relationships
  • Strong interpersonal skills, including the ability to lead and influence more senior stakeholders

Quality Assurance Engineer Associate Resume Examples & Samples

  • Review and approval of manufacturing work instructions and test procedures
  • Quality Engineering support of assembly, integration, and test activities
  • Control and disposition of nonconforming hardware
  • Root cause analysis and implementation of robust corrective actions
  • Review and approval of hardware drawings
  • "As-built versus as-designed" reconciliation
  • Document final review and closeout
  • Participation in reviews such as Material Review Boards (MRB), Failure Review Boards (FRB), Product Certification Boards (PCB), and Test Readiness Reviews (TRR)
  • Periodic presentations of Program Quality Assurance status to Senior Management team
  • Bachelor’s degree from an accredited college in a technical discipline (e.g., engineering field) or equivalent discipline (e.g., math, physics, chemistry, etc.)
  • Proficient skill level with Microsoft Office applications: Word, Excel, Power Point and Access
  • Willingness and ability to obtain a Special Programs SCI Access
  • Experience in the documentation and disposition of non-conforming products
  • Experience in establishing performance metrics for identifying process improvement
  • Experience with use of Statistical Process Control
  • Experience in using Apollo Root Cause, Fault Tree, or other cause and effect analysis methods
  • Ability to interpret product drawings and specifications
  • General knowledge of AS9100 principles

Senior Associate for Quality Assurance Resume Examples & Samples

  • Facilitate the document change control process from initiation through document effectivity
  • Review and may provide final Quality approval of Standard Operating Procedures (SOP’s), Forms, Master Production Records (MPR’s), and Solution Lot Records (SLR’s) related to Manufacturing/Packaging operations
  • Provide training to Site personnel on departmental SOP’s, Quality Systems documents and Qualifying Events as related to QA
  • Provide QA representation and guidance for manufacturing on issues related to Documentation and Compliance
  • Provide technical assistance to manufacturing operations as related to compliance requirements
  • Lead department projects and participate in Global Documentation Quality system teams/projects and devise implementation plans
  • Develop, review and implement improved practices and procedural-based documents. Demonstrate ability to resolve issues with customers independently with a commitment to customer service. Revise and perform biennial review of procedural-based documents
  • Lead internal/self-inspection audits to assure cGMP compliance
  • Provide QA support and representation for documentation procedures during Regulatory inspections
  • Minimum 5-8 years of experience in a regulated environment
  • Experience in working in a Quality Management System
  • It is a plus if you have an ASQ certification or an ISPE, PDA membership or equivalent
  • Fluency in English is required; ability to speak and write Danish is a plus

Associate Director, Audit Quality Assurance Resume Examples & Samples

  • Working closely with PPG head, perform quality assurance work within the GIA
  • Working closely with GIA management to improve quality assurance practices, risk assessment and annual Audit Plan strategy
  • Through internal quality assessment reviews, identifying risk areas to establish and support a strong audit process that evaluates the controls in place which mitigate risks
  • Plan, execute and complete the External Quality Assessment required by IIA ("Institute of Internal Auditors")
  • Plan and execute training programs to both internal GIA members and co-sourcing partners. These activities include, but are not limited to, conducting skill assessments, defining areas of improvements, setting timelines, obtaining necessary resources, managing and executing trainings to GIA and co-sourcing partners
  • Identify global audit or risk trends by maintaining a thorough and vast knowledge and understanding of audit issues and industry updates through consulting with industry counterparts and experts, attending training courses, continuing education etc
  • Building external collaborative networks and internal relationships with cross-functional areas to further develop and increase support for the Audit Program and individual audits and initiatives and to help enhance the reputation of the PPG function of GIA
  • Supporting other Takeda Internal Audit teams in Japan, Zurich and Deerfield on an as needed basis for either project-based and/ or other activities that pertain to quality improvement areas of work
  • Assisting and/ or educating non-technical audit colleagues in understanding data risk and controls
  • Performing ad hoc activities as requested by the Regional Heads
  • Undergraduate Degree or higher- preferably in Accounting, Business or related discipline
  • A minimum of ten years of progressive experience in audit, or controllership within Big 4, Industry or combination with strong internal audit experiences, of which, 3-4 years of extensive experiences of conducting quality reviews of internal audit works in global auditing environment
  • Knowledge of fundamental Internal or external audits and the agility to keep abreast of the evolving global internal audit environment
  • Strong project management, written and verbal communication skills
  • Experience and skill in managing multiple simultaneous projects
  • Ability to lead others in the review of audit reports and other deliverables, best practices including assessing, advising, designing, facilitating and/or recommending complex, global, regulatory compliance, risk management, and/or internal audit organization structures, policies and procedures
  • Self-starter and a team player, manage multi-task, and work effectively under tight schedule with high pressure
  • Be the in-house expert in order to maximize benefit and perspective to audit teams
  • Work with other Subject Matter Experts to provide training/support as needed across GIA
  • Valid passport with ability to travel internationally

Associate Director of Quality Assurance Resume Examples & Samples

  • B.S. in Engineering, Physical Science or Statistics, required
  • 15 years of collective experience in quality and product development
  • Must have in-depth knowledge of domestic (FDA) and International regulatory requirements for the medical device industry
  • 5 years developing and improving, efficient and effective product development processes, preferably for Medical Devices including electro-mechanical devices

Quality Assurance Research Associate Resume Examples & Samples

  • Theoretical knowledge of Public Health such as typically acquired by a Bachelor's degree or equivalent combination of educational and experience
  • Experience in Alzheimer’s disease clinical research trials. Knowledge of clinical trials components including statistics, study methodology, informed consent, eligibility, and adverse events. Demonstrated success and skill at researching, analyzing, and evaluating information for preparation of clinical research protocols
  • Demonstrated knowledge of databases including design, development, management, and usage. Understanding of relational and object oriented databases, data and file types, and user interface design
  • Skill to self-direct work, follow through on assignments, identify problems and recommend course of action for resolution. Demonstrated ability to organize and perform tasks independently, and prioritize tasks in a fast-paced environment
  • Knowledge of scientific research, and the willingness and ability to learn new skills, research methods, and scientific principles
  • Experience in presenting technical data in oral and written formats and producing reports using relational databases
  • Basic knowledge and medical terminology associated with Alzheimer's and experience processing clinical case report form data
  • Knowledge of PC computers, with experience using word processing, MS Office, Adobe Acrobat, SQL queries, and database systems. Knowledge of e-mail systems. Ability to learn new software programs as needed
  • Experience using data tables and data dictionaries

Quality Assurance Records Associate Resume Examples & Samples

  • Assist the device history records group by reviewing documentation, ensuring compliance with GMP and company SOP’s, making sure projects are running within specifications
  • Holding and Releasing product using SAP
  • Generating non conformances
  • Releasing or holding product on production floor as needed
  • Filing, scanning of batch records

Quality Assurance Engineer, Associate Resume Examples & Samples

  • BS degree with 0-2 years of experience (recent graduates encouraged to apply)
  • Must be proficient in Windows, MS Word, Excel and PowerPoint
  • Possess good technical communications and team building skills
  • Ability to problem solve and critically think
  • Ability to prioritize tasks and work independently
  • BS in Mechanical Engineering or Industrial Engineering or a related technical field
  • Recent experience operating a CMM
  • Certified IPC-A-610/620 Inspector
  • Recent experience working in an AS9100C environment
  • Experience working on DOD electromechanical products
  • Experience with geometric dimensioning and tolerancing in accordance with ANSI/ASME Y14.5

Quality Assurance QAR Associate Resume Examples & Samples

  • Responds to requests and calls from customers related to client specific programs and products
  • Identifies and responds to customer’s needs based on designated procedures of account/client
  • Makes attempts to resolve issues and deescalate issues of irate or dissatisfied clients
  • Escalates calls to supervisor when necessary and appropriate
  • Responds to requests for assistance and/or possible processing of credit card authorizations
  • Tracks call related information of each call received for auditing and reporting purposes
  • Provides feedback reports on call issues related to downtime and/or training issues
  • High School Diploma or GED required; graduation from a college with an Associate’s degree preferred
  • Customer service experience
  • Phone related customer service
  • Familiarity with Microsoft Windows, Word, and Excel applications
  • May require client specific bilingual language requirement, as necessary
  • Knowledge of product/procedures
  • Ability to use phone and computer systems
  • Strong listening/comprehension skills
  • Ability to stay composed and objective
  • Patience/empathetic

Associate Know Your Customer Quality Assurance Resume Examples & Samples

  • Perform ongoing formal testing of completed KYC records (which includes Global Investment Management Transfer Agents/ Unconventional clients) to ensure standards are met
  • Work with Global Partners to ensure consistency with the Global QA framework and governance approach
  • Review discrepancies or newly discovered trends with QA Managers in CAO for proper disposition and potential amendments to procedures
  • 8+ years of experience with Financial Services industry, AML/BSA, KYC, Sanctions, Compliance, Investigative or Quality Assurance background preferred
  • Results-oriented Team Player
  • Must be detail oriented, well organized, and a self starter
  • Intermediate level skills working with the MS Office suite of tools, with an emphasis on Excel and PowerPoint

Quality Assurance QAR Associate Resume Examples & Samples

  • 1-2 years of outbound sales or telemarketing experience preferred
  • 2-3 years customer service experience with a strong emphasis on retail sales is preferred
  • Must be Bilingual in English and Spanish
  • Ability to handle high call volumes and make sound business decisions
  • Knowledge of telephone sales techniques is preferred
  • Attention to detail and quality-oriented
  • Highly energetic with motivation to assist Customers and other team members
  • Confident and positive attitude
  • Adaptive to change
  • Ability to lead a consultative conversation
  • Demonstrate personal responsibility (i.e., attendance, punctuality, ownership of day-to-day activities)
  • Relationship Management, Sales and/or Customer Service experience
  • Analytical & critical thinking skills
  • Proven ability to resolve objections
  • Experience in speaking with all levels of decision-makers
  • Must exhibit a demonstrated track record of quality/compliance adherence
  • Good interpersonal and problem solving skills
  • Active listening skills
  • Ability to work a flexible schedule, including weekends and holidays
  • Monitor and evaluate customer contacts to ensure world class quality and call efficiency
  • Provide value added feedback to Quality Manager and Supervisors on how to improve call handling and increase knowledge of process and procedures to drive quality improvement
  • Data collection to ensure compliance of business policies (deep dive analysis)
  • Send out daily alerts and reporting summaries based on findings
  • Identify training, quality and operational needs, process change requirements, and competitive activity
  • Identify key people, process and system barriers to success
  • Research all aspects of projects & processes to make solid and substantiated recommendations back to the business
  • Attend weekly calibration sessions, continuous training (online and instructional led training) and actively participate in the learning process
  • Provide monthly summaries of live listening and deep dive analysis