The role
03As an Associate III – Integrated Downstream Quality Operations, you will support Quality Assurance activities across downstream GMP manufacturing operations and equipment, working closely with Manufacturing, Process Engineering, Manufacturing Sciences and Automation teams.
01Provide QA shopfloor oversight for downstream manufacturing operations
02Review electronic batch records (eBR), electronic logbooks, LIMS records and samples
03Review and approve GMP Manufacturing and Engineering documentation
04Manage minor and major deviations and support investigations
05Support CAPAs, change controls and equipment-related quality activities
06Provide Quality oversight for equipment qualification, work orders, P&IDs, qualification protocols and calibration deviations
07Support column packing/unpacking and chromatography review and release
08Perform Quality oversight of PLM, CMMS and Kneat activities
09Participate in batch record review and close-out in preparation for batch release
10Support equipment controls and release during GMP CAPEX/OPEX projects, shutdowns and new product introductions
11Participate in the Quality On-Call rotation
12Collaborate cross-functionally to ensure compliance with applicable GMP and regulatory requirements
