QA Specialist II - Operations

Responsibilities

• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
• Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
• Review and approve master batch records for the timely initiation of GxP manufacturing activities.
• Responsible for quality oversight and administration of the deviation/investigation and CAPA programs.
• Evaluate deviation incidences and determine which warrant escalation to an investigation, quality review and approval of investigations, and create and monitor the associated 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 ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner.
• 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.
• Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
• Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization.
• Coordinate change control review meetings.
• Monitor status of change controls 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 any documentation and compliance concerns.
• Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable.
• Ensures site readiness for regulatory inspections.

Qualifications

• Bachelor’s Degree in a relevant scientific discipline preferred with a minimum of 5-7 years of pharmaceutical or biotech industry experience with 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 working 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.
• Able to make risk-based decisions and resolve issues with minimal guidance.
• Excellent interpersonal skills and the ability to communicate well orally and in writing.
• Proficiency in MS Office including Word, Excel, Access and Visio.
• Ability to work in a dynamic, fast-paced work 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.
• Less than 10% travel.