QA Specialist, I

for this role includes Batch Record Review, Lot Disposition, and Quality System review. This position will also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs. In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products.

• ◆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 batch 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
• ◆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, and CAPAs
• ◆Review, develop, and approve quality system procedures, specifications, and test methods
• ◆Review and approve CAPAs to prevent recurrence of deviations
• ◆Review and approve Change Control documentation
• ◆Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates 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
• ◆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
• ◆Performs other duties as assigned.

• ✓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
• ✓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
• ✓Exceptional organizational skills and attention to detail
• ✓Ability 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
• ✓Excellent verbal and written communication skills required
• ✓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