Qa Specialist Ii - Ops

About the role

The QA Specialist II plays a crucial role in ensuring the quality of products and compliance with internal procedures and external standards. They are responsible for various duties including Batch Record Review, Lot Disposition, and Quality System review.

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 communicating release needs throughout the organization.
• Review and approve master batch records for the timely initiation of GxP manufacturing activities.
• 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.
• 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.
• Maintain and 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.
• 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.
• Ensure 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.
• Preferred 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.

Benefits

This position may require additional hours and/or weekend work.

Pay

N/A

Schedule

N/A