Qa Specialist Ii - Ops

About the role

We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. The QA Specialist II will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities include Batch Record Review, Lot Disposition, and Quality System review. This position may also evaluate deviation incidences, determine escalation needs, review and approve investigations, and create and monitor associated CAPAs. The role offers the opportunity to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products.

Responsibilities

• Perform review of batch documentation for release of internal and external clinical/commercial products, ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
• Prioritize record review in support of business needs, maintain batch status, and communicate release needs throughout the organization.
• Review and approve master batch records for timely initiation of GxP manufacturing activities.
• Provide 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; provide status reports, including relevant quality metrics, and participate in the management review process.
• 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, Investigation protocols/reports, and validation protocols/reports as applicable.
• Ensure site readiness for regulatory inspections.

Qualifications

• Bachelor’s Degree in a relevant scientific discipline preferred.
• Minimum of 5-7 years of pharmaceutical or biotech industry experience with 3+ years 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 experience with international regulations such as ICH.
• Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9.
• ASQ certification preferred.
• Exceptional organizational skills and attention to detail.
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Excellent interpersonal and communication skills, both oral and written.
• Proficiency in MS Office including Word, Excel, Access, and Visio.
• Ability to work in a dynamic, fast-paced environment.
• Honesty, integrity, respect, and courtesy with all colleagues.
• Creative with the ability to work with minimal supervision and balanced with independent thinking.
• Resilient through operational and organizational change.

Schedule

• Less than 10% travel.
• This position may require additional hours and/or weekend work.