Qa Operations Specialist
Current
Charlton, Massachusetts, United States
- Operations oversight and support for internal/external manufacturing operations including review and approval of protocolsand reports, master batch records, executed batch records and QC data verifications
- QA Operations on the floor support during manufacturing as needed to perform real time batch record and logbook reviewsalong with compliance observation of processing
- Active involvement in support of cGMP inspections from regulatory authorities
- Coordinate, prepare and approve the release process documentation for LFB products
- Assists with the management of deviations, change controls, corrective and preventive actions