QA SPECIALIST I - OPS

About the role

The QA Specialist will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. This position may also be responsible for evaluating deviation incidences, determining escalation needs, quality review and approval of investigations, and creating and monitoring 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 products/commercial products, ensuring compliance with cGMPs, site SOPs, and regulatory requirements.
• Prioritize record review in support of business needs, including maintaining batch status and communicating release needs throughout the organization.
• Review and approve master batch records for the 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 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.

Requirements

• Bachelor’s Degree in a relevant scientific field is preferred.
• 3-5 years of pharmaceutical or biotech industry experience.
• 2+ years of experience in a QA Operations role supporting late-stage clinical and/or commercial production.
• Knowledge of laboratory and production equipment and IQ/OQ/PQ.
• Exposure to RCA, technical writing, and working with quality-related investigations.
• An equivalent combination of experience and education may be considered.
• Exposure to lean operational excellence highly desirable.
• Knowledge of FDA regulations (i.e., 21 CFR Part 820).
• Knowledge and ability to apply basic scientific principles to solve operational and routine quality tasks.
• Knowledge and exposure to using Risk Management Tools (FMEA, PHA, etc.).
• Scientific, technical, and mechanical subject matter comprehension and aptitude.
• Able to articulate scientific and technical subject matter.

Skills

• ASQ certification is preferred.
• Strong organizational skills and attention to detail.
• Ability to make risk-based decisions and resolve issues with minimal guidance.
• Demonstrated positive interpersonal skills and the ability to communicate well orally and in writing.
• Proficiency in MS Office including Word and Excel.
• Ability to work in a dynamic, fast-paced work environment.
• Honesty, integrity, respect, and courtesy with all colleagues.
• Able to work with some limited supervision and escalate issues as needed.
• Flexible and adaptable through operational and organizational change.