Senior Specialist, GMP Operational Quality ( On-Site, 2nd Shift)
Vertex Pharmaceuticals
- Boston, MA
- Permanent
- Full-time
- Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems.
- Responsible for approval of COAs, generating BSE/TSE statement and product labelling.
- Responsible for archival of batch records and other supporting documents in electronic Document Management System (eDMS).
- Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment.
- Review and approval of Manufacturing documents.
- Responsible for raw material release, area clearance, line clearance and equipment release.
- May be required to assist with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs.
- Provide QA support of change controls, GMP investigations and CAPAs.
- Participate in compliance walkthroughs and help drive the closure of any audit observations.
- Responsible for identifying risks and communicating gaps for GMP process/systems.
- Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc.
- Participate in continuous improvements of department processes.
- Participate in inspection readiness and support activities.
- Participate in process improvement initiatives and ongoing Project (as necessary).
- Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner.
- Demonstrated success by independently leading cross-functional teams
- Experience providing QA support and oversight of GMP manufacturing operation including equipment/ facilities qualification, utilities and batch release.
- Experience successfully leading event investigations, Root Cause Analysis and CAPA Experience with network based applications such as Oracle, Veeva
- Master’s degree with 2-3 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field with minimum 5 years of relevant work experience, or relevant comparable background.