QA Specialist II-Operations

PCI WI Lyophilization Services Madison-posted about 1 year ago
Full-time • Mid Level
Madison, WI
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The QA Specialist II at PCI Pharma Services plays a crucial role in ensuring the quality of products and compliance with internal procedures and external standards. This position involves batch record review, lot disposition, and quality system review, with opportunities to shape and transform GxP programs by providing QA expertise for both clinical and commercial products.

  • Perform review of batch documentation for release of internal and external clinical products/commercial products, ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
  • Prioritize record review in support of business needs, maintaining batch status and communicating release needs throughout the organization.
  • Review and approve master batch records for timely initiation of GxP manufacturing activities.
  • Responsible for quality oversight and administration of the deviation/investigation and CAPA programs.
  • Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance.
  • Provide direction for complex investigations and CAPAs.
  • Ensure timely, accurate, and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations, and CAPAs.
  • Review, develop, and improve quality system procedures, specifications, and test methods.
  • Review and approve CAPAs to prevent recurrence of deviations.
  • Review and approve Change Control documentation.
  • Track investigations and change control for timely completion, providing status reports including relevant quality metrics.
  • Establish collaborative relationships with internal and external customers to address quality and compliance matters.
  • Monitor, identify, and propose quality process and system improvements.
  • Lead improvement projects and communicate status to management.
  • Serve as QA representative to cross-functional project teams such as tech transfer, process validation, and process improvement.
  • Coordinate change control review meetings and facilitate the approval process.
  • Perform risk assessments to comply with internal procedures and external guidelines.
  • Provide training on department-specific procedures and systems.
  • Interface with clients to address documentation and compliance concerns.
  • Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, and Investigation protocols/reports.
  • Bachelor's Degree in a relevant scientific discipline preferred.
  • Minimum of 5-7 years of pharmaceutical or biotech industry experience.
  • 3+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production.
  • Experience performing RCA, technical writing, and working with quality-related investigations.
  • Knowledge of laboratory and production equipment and IQ/OQ/PQ.
  • Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience with international regulations such as ICH.
  • Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
  • ASQ certification preferred.
  • Competitive rewards program
  • Opportunities for professional development
  • Inclusive workplace culture
  • Focus on quality and operational excellence
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