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Sr. QA Analyst

Company: QualStaff Resources
Location: Mesa
Posted on: May 12, 2022

Job Description:

Job DescriptionSr. QA Analyst Summary:Key contributor to the administration of the following compliance functions: DHF documentation review, Corrective and Preventive Action (CAPA) and Internal Audits. Assist management to ensure that products, procedures, processes, contracts and services comply with applicable federal and state rules and regulations; as well as internal standards. Essential Duties and Responsibilities:

  • Review Verification and Validation protocols and executions for accuracy and completeness.
  • Review DHF documentation for content and completion of required deliverables. Provide guidance as necessary to ensure appropriate content on documentation and verification of accuracy.
  • Review and audit DHF documentation assuring traceability with objective evidence.
  • Review CAPA documentation for content and completion of required deliverables. Provide guidance as necessary to ensure appropriate depth of investigation and corrective and/or preventive actions. Assess effectiveness of corrective and preventive actions. Prepare CAPA Review Board meeting agenda and minutes.
  • Review nonconformance trending to identify need for corrective or preventive actions.
  • Perform Internal Audits as Lead Auditor or member of the Audit Team. Participate in audit preparation, execution and audit reporting. Track completion of audit responses and verify effectiveness of actions taken.
  • Compile CAPA and Internal Audit performance metrics for review with management.
  • Perform duties of Recall Coordinator in association with the Company's Corrections and Removals Policy.
  • Create or revise Standard Operating Procedures and Work Instructions governing the Company's compliance functions.
  • Assist management with continuous improvement of processes and systems supporting the Company's compliance functions.
  • Stay current on applicable FDA, ISO and other applicable industry requirements. Monitor external publication sources for issues applicable to the Company.
  • Create training materials and execute training as necessary to communicate process requirements and provide guidance to user community.
  • Conduct investigations into potential quality / compliance concerns. Keep management informed of issues.
  • Perform other tasks as assigned to enable organizational and quality objectives to be met. Required Qualifications:
    • Minimum 4 years of Quality Assurance or Compliance experience in the medical device and/or pharmaceutical industries.
    • Good understanding of QMS as applied to medical devices.
    • Experience can substitute for degree requirements.
    • Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
    • Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
    • Ability to define problems, collect data, establish facts, and draw valid conclusions.
    • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. Preferred Qualifications:
      • Direct experience with Nonconforming Material, CAPA, and Internal Auditing preferred.
      • Quality System Auditor / Lead Auditor certification desiredFunctional DescriptionSupports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments. Functional/Business Knowledge
        • A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways.
        • Demonstrates further technical development and a track record of project success.
        • Demonstrates an ability to coordinate multiple projects simultaneously.
        • Considered a specialist in the field within the function.Scope
          • Assists in determining objectives of assignment. Plan schedules and arranges own activities in accomplishing objectives.
          • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
          • Networks with senior internal and external colleagues in own area of expertise.Judgement
            • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
            • Normally receives little instruction on day-to-day work, general instructions on new assignments.Experience and Education
              • Typically requires a Bachelors degree and a minimum of 5-8 years of related experience.

Keywords: QualStaff Resources, Mesa , Sr. QA Analyst, Professions , Mesa, Arizona

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