QA Specialist, I

Position Title: QA Specialist I • Location: Bedford, New Hampshire • Department: Quality Assurance • Reporting To: QA Supervisor, External QA • Responsible For (Staff): No

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 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.

Qualifications

• 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
• ASQ certification preferred