Lead Quality Assurance Specialist, uniQure Inc., Lexington, MA

Support daily quality operations via oversight of all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), investigations, excursions, Out of Specifications (OOS), change control, batch review and disposition, data integrity, and training in support of biologics manufacturing production.

• Supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
• Managing work of other junior level Quality Assurance Specialists, providing mentorship, coaching and training as needed.
• Reviewing and approving batch records and solution lot records.
• Reviewing and approving preventative maintenance, calibration, and work order documentation.
• Performing reviews of Validation Lifecycle documents including, but not limited to, Functional, Detailed Design, Configuration and User Requirement Specifications (FS/DDS/CS/URS) and Factory and Site Acceptance Test (FAT/SAT) protocols and Reports from a quality perspective to ensure compliance to internal requirements.
• Supporting internal and external audits.
• Reviewing, assisting in the investigation of, and approving deviations related to Manufacturing operations.
• Providing on-the-floor Quality Assurance support for manufacturing activities.
• Representing Quality Assurance on project teams and in meetings.
• Supporting the continuous improvement and oversight of Quality Management System procedures.
• Supporting HR functions for Quality Assurance Team.

Requirements:

Position requires a Bachelor's degree in Chemistry, Pharmacy or a closely related field and 5 Year(s) of progressively responsible experience as a Quality Assurance Specialist or closely-related role in pharma/biotech setting.

Experience, which may have been gained concurrently with primary requirement above, must include the following:

5 years of experience with:

• Administering Quality Management systems and procedures, including: deviations, change controls and CAPAs;
• Creating and maintaining on the floor QA documents in accordance with cGMP.
• Working knowledge of FDA and EU regulatory requirements as they pertain to biotech and pharmaceuticals.
• Working with the following software: MasterControl, LIMs, Trackwise, LabX, Blue Mountain, and CMS.

1 year of experience with:

• Internal audits and supporting external audits.
• Working in and providing QA support in the fill finish environment.

The position is on site, with remote work permitted 1 to 2 days/week.