Quality Systems Analyst Resume Samples

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BH
B Howell
Brittany
Howell
69745 Christian Lakes
Chicago
IL
+1 (555) 228 6310
69745 Christian Lakes
Chicago
IL
Phone
p +1 (555) 228 6310
Experience Experience
Dallas, TX
Quality Systems Analyst
Dallas, TX
Schumm and Sons
Dallas, TX
Quality Systems Analyst
  • Provide support/resources for Process Testing, sample collection during grade development efforts and project work mill-wide
  • Assists in the development of Quality and Process Improvement budgets
  • Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff
  • · POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures related to work activities performed in area of responsibility
  • · SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter the work area
  • Assist in change control coordination for external and in-network bulk and packed product for Mylan Ireland
  • Manages change management processes including
Dallas, TX
Quality Systems Analyst / Specialist
Dallas, TX
Ortiz LLC
Dallas, TX
Quality Systems Analyst / Specialist
  • Support the implementation of the Operational Excellence Programme on the site by identifying and implementing improvements
  • To maintain and develop the SOP system in relation to the update, logging and distribution of SOP’s for the entire facility
  • To administer and develop the Change Control System and Deviation System in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items in relation to both
  • To administer and develop the environmental monitoring system
  • To collate information and assist in the preparation of reports in relation to Annual Product reviews for all products manufactured on site
  • To administer and develop the on- hold and reject system
  • To administer and develop the complaints system, including the pharmacovigilance system, in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items
present
Boston, MA
Senior Quality Systems Analyst
Boston, MA
Larkin-Monahan
present
Boston, MA
Senior Quality Systems Analyst
present
  • 20% Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs)
  • Develop and manage UAT Test Strategy, Test Plan, Test Scenario and Test Summary documentation
  • Provide input to, or participate in, process improvement initiatives around testing
  • Develop, gather, and measure relevant metrics and present as part of Management Review
  • Work concurrently on several projects, each with specific instructions that may differ from project to project
  • Ensure that quality processes are carried out through all phases of the Software Development Lifecycle
  • Provide guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems
Education Education
Bachelor’s Degree in Pharmaceutical
Bachelor’s Degree in Pharmaceutical
Michigan State University
Bachelor’s Degree in Pharmaceutical
Skills Skills
  • Ability to make good judgments and quick decisions
  • Excellent planning and organizational skills with the ability to handle multiple tasks
  • Proficient in Microsoft Word and Excel, and other basic computer software
  • Proficiency with Microsoft Excel pivot tables and advanced functions
  • Excellent analytical and judgment capabilities and communication skills, and the ability to work with management across the plant
  • Self-starter with the ability to work with little supervision. Good time management skills
  • Ability to read and interpret Drawings per ASME Y14.5 and Technical Data and Documents
  • Proficient in Microsoft Word, Excel and PowerPoint at an intermediate level
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Demonstrated experience and skill with intermediate level of Statistical knowledge
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15 Quality Systems Analyst resume templates

1

Senior Quality Systems Analyst Resume Examples & Samples

  • 20% Maintain status reports for systems and drive compliance to agreed upon dates
  • 20% Support the BPOs in providing technical, procedural, and compliance based guidance to system users as needed
  • 20% Perform analysis and report on trend data. Report and escalate system and process performance metrics to the Business Process Owners (BPOs)
  • 20% Support the BPOs in follow-up with record owners and tracking and trending of record status
  • 10% Support training for Quality Systems processes as needed
  • 10% Other duties as assigned by management
  • College degree required
  • Change Control, CAPA and Deviation experience related to GMP / GDP / Medical Device required
  • TrackWise experience required
2

IT Quality Systems Analyst Resume Examples & Samples

  • 10-20% Strategic Partnering
  • Work with stakeholders to understand requirements and provide operational oversight for the implementation of approved solutions
  • Keep abreast of technology trends in the market and evaluate for potential value to Shire
  • 40-60% Plan and Build
  • Establish and coordinate initiatives that are part of the Tech Ops IT portfolio
  • Evaluate proposed IT infrastructure changes to determine potential impacts to systems operations and compliance
  • Participate in Tech Ops meetings where appropriate to understand business requirements
  • Work closely with Shire IT business project teams during planning and design phases to ensure appropriate solutions
  • Consult during the selection of external service providers
  • 20-30% Run
  • Implement necessary processes and tools to effectively manage the technical/operational architecture including governance, internal standards, processes, modeling capabilities and operational support
  • Function as a subject matter expert for Tech Ops IT Quality applications and interfaces and demonstrate ability to solution-engineer application related fixes or projects
  • Provide configuration solutions and advice and develop customizations, as required, within the context of technical standards
  • Develop new features requested through requirements gathering from projects, pilots or tests and implement these features specifically or broadly, as the situation dictates
  • Create system documentation and ensure that application components and design are clearly documented and assessed based on risk
  • Assist with and contribute to application validation efforts, including installation qualification, operational and performance qualification
  • Partner proactively with IT infrastructure partners to ensure optimum operational performance of delivered solutions
  • Bachelor’s degree in information technology, computer science, engineering, marketing and/or business administration (required)
  • More than 3 years relevant IT/business experience, including project scoping, analysis, and documentation of business and technical requirements (required)
  • Experience in the Pharmaceuticals or Life Sciences industry (preferred)
  • Experience consulting or working in a complex, global matrix organization (preferred)
  • Knowledge of IT Computer systems Validation processes (required)
3

Quality Systems Analyst Resume Examples & Samples

  • Drives compliant execution of the following for their assigned processes and projects
  • Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements
  • Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner
  • Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards
  • Responsible for identifying and communicating the need for process improvement opportunities to responsible management
  • Support the assigned processes during internal and external audits
  • Where applicable, conducts internal audits to ensure compliance to regulatory and customer requirements
4

Quality Systems Analyst Resume Examples & Samples

  • Gain an understanding of the Company Lab processes, configuration and enhancement points for Labware and SAP QM modules across our various divisions, including integration design with other systems
  • Design, develop and deliver enhancements in the form of specific mini-projects and change requests in the Labware LIMSand SAP QM systems
  • Take a lead role from a quality perspective on multiple implementations and continuous improvement projects, including
5

Quality Systems Analyst Resume Examples & Samples

  • Ensure consistent and correct execution of Quality System procedures at the site to maintain the quality and compliance of processes and records for Non Conformance, CAPA, Internal Audit Observations, Quality report and Management Review
  • Develop competency of resources at the site by providing training and guidance on the execution and documentation of Non Conformance, CAPA, Internal Audit Observations, Quality reporting and Management Review processes
  • Support on site the timely collection, escalation and reporting of Quality System metrics to management
  • Support the deployment of process initiatives impacting the site that promote the continuous improvement of the Quality System and ensure continuity of the application of globally shared processes and systems at site level
  • Participate in audit readiness; assist in Internal and External audits; serve as Subject Matter Expert during audits; supporting the investigation, response, and remediation of site-specific Quality System audit observations
  • Manage on site Document Control, including management of change documentation, on-site administration of the change control system, and archival of documents on site
  • Bachelor’s or Master’s Degree in Engineering, Natural Sciences or similar
  • 2 years related experience in Medical Device or Pharmaceutical environment, or equivalent combination of education and experience is an advantage
  • Experience in Quality Auditing and notified body inspections is preferred
  • Advanced use of computer and software applications is required
  • Ability to analyze, graph, and present data in a way that facilitates and drives decision making
6

Quality Systems Analyst Resume Examples & Samples

  • Ensure all quality assurance activities are appropriately satisfied
  • Build positive professional relationships with internal and external customers
  • Develop and manage UAT Test Strategy, Test Plan, Test Scenario and Test Summary documentation
  • Log, track, and manage defects to closure
  • Champion and apply a risk-based testing approach
  • Provide input to, or participate in, process improvement initiatives around testing
  • Apply situational leadership by making effective and efficient testing decisions on behalf of the project
  • 3+ years of experience with testing web applications, Windows-based applications, and / or mainframe systems
  • MS Office proficiency including Access, Visio, and MS Project
  • Ability to understand and articulate business / system functionality requirements and / or process flows as it relates to test cases & test results
  • Ability to meet project-related deadlines
  • Ability to work as part of a self-directed team where tasks are self-determined, as opposed to specifically assigned
  • Strong leadership and coordination skills
  • Excellent interpersonal skills at both an individual and team level
  • 3+ year experience using test management tools such as Application Lifecycle Management (ALM)
  • Experience in business analysis and / or project management
  • 3+ years UAT testing experience for enterprise level applications including developing and implementing effective test plans and test cases
7

Senior Quality Systems Analyst Resume Examples & Samples

  • Participate in User Acceptance Testing (UAT) for multiple functional work areas on varying applications and platforms
  • Effectively analyze and decompose business requirements into testable components
  • Mentor other IT Quality System Analysts
  • Work closely with the Project Team to identify risks and UAT scope early in the project lifecycle
  • Ensure resource requirements are met for testing environments, UAT cycles and related components required to support adequate test execution
  • Monitor, measure and communicate test results
  • Create, prepare, and obtain sign-off for UAT documentation
  • As required, participate in end-to-end testing cycles across multiple business segments
  • As required, participate in Business Partner testing cycles with external customers
  • BS in Computer Science or related field or equivalent
  • 5+ years quality assurance team leadership experience
  • 5+ years of experience understanding all phase of the Software Development Life Cycle
  • MS Office proficiency including Access, Visio, and Project
  • Ability to understand and articulate business / system functionality requirements and/or process flows as it relates to test cases & test results
  • Demonstrate solid understanding of UAT Testing methodologies
  • Experience with testing web applications, Windows-based applications, and/or mainframe systems
  • Ability to meet project - related deadlines
  • Ability to work as part of a self - directed team where tasks are self-determined, as opposed to specifically assigned
  • Previous experience working with Agile
  • Previous experience in the Health Insurance industry
  • 5+ year experience using test management tools such as Application Lifecycle Management
  • 5+ years UAT testing experience for enterprise level applications including developing and implementing effective test plans and test cases
8

Senior IT Quality Systems Analyst Resume Examples & Samples

  • 12+ years of IT experience with a GED/High School Graduate
  • 8+ years of IT experience with Associate’s Degree
  • 4+ years of IT experience with a Bachelor’s Degree
  • 2+ years of IT experience with a Master’s Degree
  • System validation experience
  • Knowledge and direct experience in the application of software development lifecycles, document management best practices, and system validation compliance within a regulated environment
  • Working knowledge of quality system regulations, GMPs and ISO requirements
  • Practical experience with regulatory compliance and risk assessments including those associated with 21 CFR Part 11
  • Strong oral and written communication skills including technical writing, presentations and classroom instruction
  • Proficient with use of Microsoft Office tools: Word, Excel, Visio, PowerPoint
9

Quality Systems Analyst Resume Examples & Samples

  • To administer and develop the Change Control System and Deviation System in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items in relation to both
  • To administer and develop the on- hold and reject system
  • Administration/co-ordination of risk assessments
  • To administer and develop the complaints system, including the pharmacovigilance system, in accordance with the relevant SOP’s at Mylan Dublin OSD and to coordinate the follow up and closure of all open items
  • To coordinate the Approved Supplier listing for raw materials
  • To participate in third party audits of Mylan Dublin OSD
  • To ensure that the systems with a GMP impact are maintained as per written procedures
  • Support the implementation of the Operational Excellence Programme on the site by identifying and implementing improvements
  • Any other duties as assigned by the Quality Manager
  • Experience in a high volume environment
  • Experience in managing change and seeking continuous improvements
10

Quality Systems Analyst Resume Examples & Samples

  • Investigations into OOT Complaints for in-network and 3rd party complaints/issues notified to Mylan
  • Ensure stability for in-network and 3rd party is scheduled and annual reports provided to Q for review
  • Review of OOS for stability notified to Mylan by in-network/3rd party suppliers
  • Review of 200+ in-network/3rd party PQRs for the release sites and notification to QA / QPs of any trends in Q that occur
  • Review of RFT figures for in-network/3rd party supplier trends and work with 3rd party to assign CAPA, and review all Audit reports for new suppliers for 3rd party product for Manufacturing License updates
  • Implementation of Quality Risk Requirements (ICH Q9) required by QP release sites to support HA inspections for review of Quality Supply chain requirements
  • Assist in change control coordination for external and in-network bulk and packed product for Mylan Ireland
  • Assist in Technical Agreement coordination for outsourced product, and support QA Manager for QA systems for Launch and 3rd party requirements
  • Experience of Quality Systems in a Pharmaceutical environment would be of benefit
  • Relevant experience in GMP/GLP environment
  • Strong organisational skills / ability to prioritize work
11

Senior Quality Systems Analyst Resume Examples & Samples

  • Mentor other Quality Systems Analysts
  • Execute tests within Web-based, Windows-based, and/or mainframe applications & environments
  • BS in Computer Science, related field or equivalent work experience
  • 5+ years of quality assurance team leadership experience
  • 5+ years of UAT testing experience for enterprise-level applications, including developing and implementing effective test plans and test cases within the Software Development Life Cycle
  • 5+ years of experience using test management tools such as Application Lifecycle Management
12

Quality Systems Analyst Resume Examples & Samples

  • Ensure that quality processes are carried out through all phases of the Software Development Lifecycle, while meeting all project-related deadlines
  • Work concurrently on several projects, each with specific instructions that may differ
  • Work independently on projects, where tasks are self-determined and not specifically assigned
  • Work with business partners, systems analysts, designers and programmers to create / analyze required project documents and ensures that quality assurance processes are incorporated
  • 3+ years of UAT testing experience for enterprise-level applications, including developing and implementing effective test plans and test cases within the Software Development Life Cycle
  • 3+ years of executing tests within Web-based or Windows-based, and/or mainframe applications & environments
  • 3+ years using test management tools
  • Bachelor's in Computer Science, related field or equivalent work experience
  • Experience using test management tools such as Application Lifecycle Management
  • Excellent interpersonal and communication skills (written and verbal) at both an individual and team level
13

Senior Quality Systems Analyst Configuration Management Resume Examples & Samples

  • Plans, develops/improves, and implements improvements changes to quality system processes and procedures; includes CAPA investigation/corrective action implementation
  • Reviews change notices for completeness and implements/coordinates the review/sign-off process to effectively place documentation under change control
  • Subject matter expert providing/assisting support of quality system tools (eg. SAP/DiaDoc); includes training others on tools/processes
  • Leads process improvement initiatives to continuously improve the effectiveness
14

Quality Systems Analyst Resume Examples & Samples

  • Manages change management processes including
  • A minimum of a Bachelor’s Degree in Chemistry, Engineering, Life Sciences, Pharmacy or similar disciplines required
  • A minimum of 5 – 8 years of experience working in a regulated industry is required, with strong understanding of GMP standards related to pharmaceutical products
  • Knowledge of GMP/GLP regulations and guidelines is a requirement
  • Knowledge of and competence in the application of Health Canada GMPs, ICH Guidelines
  • Knowledge of Process Excellence tools, thinks analytically and acts decisively
  • Strong interpersonal skills and effective performance management skills
  • Strong problem solving, partnering, and communication skills
15

Senior Quality Systems Analyst Resume Examples & Samples

  • Analyze business processes and review/write system documentation (design history file) including user requirements, risk assessments, and functional specifications. Ensure compliance of system documentation with procedures and regulatory requirements
  • Provide guidance in interpretation and correct application of 21 CFR Part 11 regulation in new and existing systems
  • Understand and follow as appropriate design control, SDLC, quality validation processes and application processes. Quality support for executing the design and development process, including risk management, for software medical devices, 510k and other regulatory submission projects
  • Support day to day quality operations related to the Change Control process in Trackwise 8
  • Review and/or update design history file documentation, protocols, system testing, reports, etc. Review executed verification/validation testing or other computer system records to ensure they are complete, accurate and compliant with cGMP requirements
  • Provides support to business functions and IT concerning quality issues and ensure conformance to established performance requirements and procedures
  • Quality support in executing the complaint/CAPA/MDR/FCA processes relating to software devices
  • Own key tasks, require moderate direction, and handle moderately complex problems
  • Stays current with federal, state, local and company-specific rules, regulations and practices
  • Develop, gather, and measure relevant metrics and present as part of Management Review
  • Identify ways to improve efficiency and effectiveness of processes as part of the Quality Management System (QMS) for software devices meeting changing business needs and regulatory / quality requirements
16

Quality Systems Analyst Resume Examples & Samples

  • Bachelor's degree and 2 years of relevant industry experience OR Associate's degree and 3 years of relevant industry experience OR High School diploma/GED and 5 years of related industry experience
  • Demonstrated experience with MS Office Applications
  • Demonstrated experience leading Problem Solving and Process Improvement teams
  • Results oriented, hands-on analyst with a strong work ethic who can operate effectively in a global collaborative environment working on multiple projects of varying size and complexity
  • Strong deviation, CAPA, and/or change management experience
  • Experience in regulatory inspections and responding to observations
  • Experience with training, coaching, and leadership
  • Practical understanding of principles of project management and team facilitation
  • Demonstrated knowledge of Excel with some VBA experience
  • Demonstrated use of LEAN and Six Sigma Tools. ~BSP
  • Interstate travel may be required. #LI-GZ
17

Quality Systems Analyst Resume Examples & Samples

  • Minimum of 5 years of experience with Quality Systems analysis, compliance, and maintenance
  • Minimum of 5 years of experience with AS9100
  • ASQ CQA, RAB or equivalent auditor certification
18

Intern, Quality Systems Analyst Resume Examples & Samples

  • Extract and organize large amounts of data generated from the Burn In stress chambers
  • Allow remote status tracking and data mining of other critical stress chambers within the lab
  • OCR program to automate and improve an existing IC chip serialization capability
  • Generate Statement of Work (SOW) based the Reliability Engineer’s requirements
  • Execute the SOW, with regular inputs and check points with the Engineer on program progress
  • Work with the Quality Systems Analyst to formulate and follow architectural and coding structure
  • Recommend technical and architectural structure for the programs in development
  • Evaluate system in test environment
  • Coordinate implementation of system to live database
  • Local applicants only
  • Experience with coding in Python, HTML, Java Script, SQL, and VBA in Excel Programming
  • Experience with Software Testing and Implementation Planning
  • Self-direction, work independently
  • Able to prioritize daily activities with minimal oversight
  • Work well in a team environment
  • Good decision making and Problem solving skills
  • Effective communication skills (Written and Verbal)
  • Ability to flex schedule as needed
  • Preferred Major: Computer Science, Computer Engineering, Computer Technology Management
  • Data analytics & reporting
19

Business / Quality Systems Analyst Resume Examples & Samples

  • Analyzes business needs, documents requirements and translates needs into functional, non-functional and/or technical specifications
  • Delivers requirements, performs analysis, and evaluates downstream business, systems, process, and/or organizational impacts
  • Plans and assists with oversight of testing processes and activities including defect identification and resolution
  • Analyzes charts and/or diagrams of the problem to be programmed and defines system requirements in terms of system capabilities
  • Develops or assists in the development of work plans, time schedules, and project task items and schedules and assists with estimating resource needs for analysts, programmers, user personnel, consultants, equipment, and prepares routine project status reports
  • Assists in the development of project cost and benefit estimates to establish project worth including the development of alternative considerations. This will result in recommendations for the installation of new systems or equipment, or to change existing systems and equipment
  • Advises the appropriate people on the implications of existing IT systems that can be applied to a problem. Identifies risks and issues, and seeks approval on complex matters
  • Checks, instructs, assigns work, and otherwise functionally directs technical staff in order to achieve desired end-results on complex problems
  • Provides subject matter expert and operational support to internal business partners
  • Bachelor’s degree in computer science or related field required. (4 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of a bachelor’s degree)
  • 8+ years experience in developing requirements and performing system analysis
  • 5+ years experience of major software systems implementation experience
  • Strong understanding of the Software Development Lifecycle (SDLC)
  • Ability to analyze and document process and data flow
  • Ability to clearly communicate ideas and solutions
  • Ability to effectively work with both internal and external clients
  • Knowledge of Health Care Industry and related business functions
  • Experience in Medicare Claims and Medicare Risk Adjustment
  • Advanced course of study in information technology, business or other field
  • Experience with project management and project control methodologies
  • Experience process re-engineering and best practice implementations
20

Quality Systems Analyst Resume Examples & Samples

  • Responsible for assuring a system/application meets its requirements and is compliant with applicable Baxter QMS documents, and the documentation set outlined in the Validation Plan for the project
  • Responsible for creating the documents required for the development and validation of the computerized system
  • Supports a BPO in all GxP regulations, compliance with internal and external procedures, and all aspects of safe, reliable, and consistent operation of the computerized system
  • Responsible for reviewing the new/revised corporate level documents per applicable procedure in areas of responsibility
  • Responsible for the reviewing/updating internal procedures as assigned
  • Demonstrates leadership and accountability
  • Train fellow employees on computerized systems, lab systems, and related lab equipment as needed
  • Develop execute validations for manufacturing processes and laboratory systems. Insure completion of all protocols and validations in a timely and appropriate manner. Report progress of protocol and validation work and significance of results. Recommend utilization of the results or changes in the scope of work or termination of projects
  • Ensure compliance with testing SOPs and specifications
  • Performs a variety of projects/studies in areas that may include Product/Process, sterilization, Cleaning and Equipment Validation, as well as projects/studies to support Manufacturing Operations
  • Writes protocols, reports, and change controls. Conducts studies/executes protocols
  • Serves as project lead with projects of intermediate scope and cross-functional teams
  • Minimum of a BA or BS preferably in the Sciences/Engineering/Math (other degrees accepted provided the individual has relevant experience -- e.g. education or employment in sciences or validations) with a minimum of 3+ years related experience or 2+ years related experience w/ an advanced degree or demonstrated performance within Technical Services
  • Excellent analytical and judgment capabilities and communication skills, and the ability to work with management across the plant
  • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
  • Ability to make good judgments and quick decisions
  • Proficient in Microsoft Word and Excel, and other basic computer software
  • Direct or indirect industry knowledge
  • Experience with maintaining LIMS applications and associated databases such as Oracle is helpful with role responsibilities
  • Experience with crystal reports and working with databases in order to setup the crystal report is helpful with role responsibilities
  • Experience with installation, administration, and maintenance of virtual server environment is helpful with role responsibilities
  • Familiarity with programming languages, such as SQL, etc
  • Ability to work independently or in teams
  • Ability to walk some distance 1-3 miles, stand for 3-6 hours and lift 10 - 40 lbs during the course of a work day as required. Ability to work any shift (1st, 2nd or 3rd) and any day of the week (7 days) as duties require
21

Quality Systems Analyst Resume Examples & Samples

  • · Ensures quality systems are effectively deployed. Performs periodic checks to verify appropriate application
  • · Uses statistical methods, quality tools and computer generated reports to continuously improve process capability. Leads and participates in quality system improvement & initiatives in a cross functional environment
  • · Determines root causes of quality issues and develops corrective actions and recommendations and documents results in the appropriate quality system
  • · Establishes, maintains and implements communications to increase awareness and promote improvement of quality issues across the business
  • · Provides audit back room support (for Notified Body, FDA, or customer audits) as required
  • · Monitors and reports Quality Management System metrics
  • · Monitor and track alignment to J&J Quality Standards and any other quality system initiatives
  • · Creates and revises documentation in change control process to improve quality system processes as needed
  • · Committed to building a positive culture
  • · Other responsibilities may be assigned & not all responsibilities listed may be assigned
  • · POLICIES: Know and follow Sterilmed and Johnson & Johnson policies and procedures related to work activities performed in area of responsibility
  • · TRAINING: Complete training in area of responsibility within allowed time-period. Training is required for changes in existing policies & procedures, for new assignments and for implementation of new policies & procedures. Complete required periodic re-training in areas such as environmental health & safety
  • · SAFETY: Follow all company safety policies & other safety precautions within work area. Promote safety to all associates that enter the work area
  • · procedures. Complete required periodic re-training and assure that required periodic re-training takes place for direct reports in areas such as environmental health & safety
  • · SAFETY: Set standards for safe behavior. Recognize and reward safe behavior in others. Ensure that direct reports employ safe practices. Enforce safety policies & procedures. Evaluate staff member’s safety performance & insure that safety is a part of each direct report’s performance appraisal
  • Required and Preferred Experience and Skills
  • · Education, Skills, & Experience Needed to Perform Position Function
  • · Bachelor degree or equivalent experience is required
  • · 1+ years in Quality Systems is required
  • · Experience in FDA regulated industry is required
  • · Knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971 is required
  • · Prior experience in the medical device industry is preferred
  • · Knowledge of Microsoft Office is required
  • · Ability to function independently as well as part of a team is required
  • · Excellent written and verbal communication skills are required
  • · Ability to manage multiple priorities in fast-paced environment is required
  • · ASQ Certification and/or Six Sigma training desired
  • · Project Management/Excellence; Quality Systems and ISO regulations
  • · Familiarity with any of the following is preferred: EZDOC, EtQ, ComplianceWire, Siebel, Microsoft Professional Office Suite (MS Word, MS Excel, MS Outlook, MS Access)
  • · This position is located in Plymouth, MN and may require some travel.Quality (Eng)
22

Quality Systems Analyst Resume Examples & Samples

  • Creates, distributes and manages reports as required
  • Maintain database of information and provide to regulators and certifying bodies as required
  • Gather and provide information for PL customer requests
  • Maintain document control system, both electronic and paper
  • Maintain FDA registrations
  • Organic program management and other programs as required
  • SharePoint system administrator
  • Develop, monitor and track action plans
  • SME on current regulatory and certifying body requirements e.g. Organic, Kosher
  • Other duties may be assigned as required
  • Working knowledge of cGMP for foods and dietary supplements
  • Working knowledge of Quality (QA/QC) in a dietary supplement manufacturing environment
  • Preferably with experience in report development and data mining
  • Experience working in manufacturing and regulatory environments would be a benefit for the associate in this role
  • Knowledge of regulatory requirements for supplements, including knowledge of CFR part 111
  • Analytical thinking/problem solving
  • Ability to Influence others
  • Ability to data mine Oracle PQM and other databases
  • Proficient in Computer Software: Oracle, PQM, Microsoft Word etc
  • Proficiency with Microsoft Excel pivot tables and advanced functions
  • Exhibit positive attitude regarding work and responsibilities
  • Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
  • Continuously look for ways to do things faster and better, while maintaining high quality standards
23

UMM Quality Systems Analyst Resume Examples & Samples

  • UMM Programming required
  • Bachelor's degree in engineering, business, or related required
  • Excellent PC skills including Excel, Word, Powerpoint
  • Familiar with the requirements of AS9100
  • Knowledge of SAP highly desired
  • US Citizen or green card holder required
24

Quality Systems Analyst Resume Examples & Samples

  • 5+ years aerospace experience in Quality Assurance related fields
  • Skilled at supporting internal and external audits for QMS
  • Must be familiar with standard Visual and Mechanical Inspection techniques and tools
  • Ability to read Drawings and other Technical Data required
  • Good communication skills required, both written and oral format
  • Ability to successfully interact with both internal and external customers on a variety of technical solutions
  • Confidence to enforce Quality Management System policies and procedures, while also working as part of a Team
  • Mechanical Inspection hands on experience
  • First Article (AS9102) Documentation experience a plus
25

Quality Systems Analyst Resume Examples & Samples

  • Administer and manage the finished product specifications database
  • Audit specifications for accuracy
  • Manage customer specifications by updating the finished product specifications database and maintaining communications with customers
  • Implement updates/programming and train users on the finished product specifications database
  • Assist in annual review of customer specifications with Production, Customer Service, Sales and Customer Solutions Group
  • Manage the Finished Products Visual Standards to ensure customer success
  • Manage and update the Test Equipment Manual
  • Administer and audit the International Standards Organization (ISO) Quality System to ensure compliance
  • Assists in the development of Quality and Process Improvement budgets
  • Develops and administers testing equipment daily reference checks
  • Manages the annual calibrations and certification processes for test equipment for the site
  • Responsible for site testing equipment, including purchasing, training, calibrations, reference checks and routine maintenance to ensure compliance
  • Assist in the validation of Finished Product Work Instructions and stand operating procedures for the paper test lab
  • Develops knowledge base in TPM/lean concepts, with the learned ability to lead problem solving activities to drive continuous improvement in area of responsibility
  • Administer and maintain all quality reporting systems in the Arkansas production areas
  • Management of reporting systems, including daily and weekly quality reports and Typical Average Value Reports
  • Provide support for Customer Certificate of Analysis (COA)
  • Participate in weekly Quality Conference calls, acts as host as needed (back-up)
  • Provide support/resources for Process Testing, sample collection during grade development efforts and project work mill-wide
  • Use proven data collection and analysis techniques to correlate data, make recommendation for corrective and/or preventative action and plans, driving to resolution of issues
  • Work with teams to ensure that requirements documentation is complete and appropriate, ensuring that the proper testing plans have been completed
  • Provide Capability Analysis and Quality Systems Analysis Reports
  • Participate in daily/weekly stand-up and other KPI-driven meetings
  • Participate in or leads Quality Assurance projects and problem-solving activities
  • Collaborate with Engineering, Maintenance, and Production teams in the development of documentation, investigations and resolution of quality issues
  • Prepare and present findings to business partners in writing and orally to assist the business partners in determining the best corrective actions to be applied
  • BS Degree in Engineering, Management Technology, Natural Science or equivalent education required
  • Minimum 4 years’ experience in the Pulp and Paper Industry strongly preferred
  • General knowledge of Process Testing and Testing Equipment required
  • Excellent planning and organizational skills with the ability to handle multiple tasks
  • Proficient in Microsoft Word, Excel and PowerPoint at an intermediate level
  • Demonstrated experience and skill with intermediate level of Statistical knowledge
  • Strong analytical and troubleshooting skills, including data verification
26

Quality Systems Analyst / Specialist Resume Examples & Samples

  • To participate in the internal audit schedule
  • To administer and develop the environmental monitoring system
  • To maintain and develop the SOP system in relation to the update, logging and distribution of SOP’s for the entire facility
  • To administer the TSE/BSE and Residual solvent compliance systems for all raw materials and contract manufactured materials by ensuring that the appropriate certification is on file for all materials
  • To collate information and assist in the preparation of reports in relation to Annual Product reviews for all products manufactured on site
  • To ensure that good GMP standards are maintained at all times
  • To ensure company procedures regarding controlled drugs are followed and assist in the audit of logbooks as required
  • Minimum of a Bachelor Degree in Science or related pharmaceutical discipline
  • Track record with the HPRA/FDA is desirable
  • A proven identifiable track record of success in a similar environment
  • Have an understanding of, or exposure to Operational Excellence principles
  • Proficiency in speaking, comprehending, reading and writing English is preferred
27

Senior Quality Systems Analyst, R&D Resume Examples & Samples

  • Adheres to environmental policy and procedures and supports department environmental objectives
  • Leads the change management, NC, investigation, CAPA and complaints day-to-day activities
  • Writes and issues stability protocols, addenda, reports, etc. including interacting with cross-functional groups to identify and implement study requirements and design
  • Leads the improvement/implementation of change management, NC, investigation, CAPA, and complaint handling best practices, policies, and procedures with specific focus in simplifying and standardizing the R&D quality system processes
  • Utilizes quality tools and science to track, trend, and analyze quality performance metrics. Identifies and takes action to prioritize and implement proactive quality systems and quality process improvements
  • Facilitates quality assurance and/or cross-functional projects regarding new product development processes and quality system improvements
  • Interacts regularly with temporary employee(s) and contractor staff to ensure an adequate flow of work activities including study setup, sample submissions, data retrieval and tabulation for existing studies, complaints handling, etc
  • Develops and conducts or coordinates quality systems training
  • A Bachelor’s Degree in scientific or engineering discipline is required
  • Minimum of 5 years of experience
  • Minimum of 2 years working experience in quality assurance, quality systems, quality control, scientific research or regulatory compliance. Graduate scientific degree can be considered in lieu of experience
  • Strong knowledge and understanding of quality systems in a regulated environment and/or strong knowledge of scientific methods
  • In depth understanding and knowledge of a broad set of regulatory requirements and ability to interpret regulations (GMP, ISO, ICH, WHO, etc.)
  • Ability to effectively manage projects that include cross-functional teams representing diversified areas
  • Excellent communication, organizational, negotiation, influencing, and interpersonal skills required
  • In depth understanding of lens manufacturing and stability principles and practices
  • Working knowledge in statistics and statistical applications1605170518
28

Senior Quality Systems Analyst Resume Examples & Samples

  • Analyze field failure data (complaints and service events) from both domestic and ROW customers, looking for failure trends by product, manufacturing site, and/or specific customer accounts
  • Interface with the KSI Complaint Handling process
  • Bachelor’s degree required (Engineering preferred)
  • 6 years of work experience in medical device regulatory, compliance and/or quality systems required
  • Experience in auditing of medical device quality systems preferred
  • Experience in leading cross-functional teams to accomplish goals and objectives required
  • Experience in training groups and in public speaking preferred
29

Senior IT Quality Systems Analyst Resume Examples & Samples

  • Lead in the assessment of IT systems software and applications to meet business needs
  • Lead in the selection, development, configuration, validation, and implementation of IT systems
  • Assist/conduct users training; Perform on-going maintenance and systems upgrade
  • Responsible for communicating process and functional requirements to the quality teams (R&D, sustaining, operations, post market)
  • Participate and lead projects in various areas of Quality Systems and Reporting with main focus on Complaint Management and Risk Management
  • Experience developing requirements and functional designs for global technology solutions
  • Experience in facilitating small to large groups through challenging discussions
  • Knowledge of SAP (e.g. Business Objects and Lumira) and other BI Applications (e.g. Spotfire and Tableau, Cognition Cockpit), Microsoft Excel macros, Cognos, Blue Mountain, Trackwise, Solidworks, etc
  • Ability to quickly learn new business areas and processes
  • Innovative problem solving skills with the ability to identify problems, drive to root cause, develop, and implement solutions independently or as part of a team
  • Self-motivated to make recommendations and initiate assignments that will improve business processes and systems
  • Goal oriented, task driven decision-making with a strong sense of accountability
  • Ability to interact within different levels of business and IT management; good organizational skills
  • Ability to manage multiple complex priorities
  • Strong oral, written, and interpersonal communication skills
  • Knowledge of 21 CFR Part 11, systems validation methodologies, HIPAA, and FDA regulatory requirements
  • Experience with working as part of a global team in a fast-paced environment
  • Advanced degree in Computer Science or business related discipline