Specialist QA I - Manufacturing Oversight
The QA Specialist I - Manufacturing Oversight performs manufacturing oversight activities to ensure compliance with policies and procedures. Oversight activities include, but are not limited to, real-time manufacturing batch record review, review of manufacturing documentation (logs, charts, etc.), and resolution of issues on the manufacturing floor.
ESSENTIALS OF THE JOB:
- Possess an understanding of Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
- Perform Quality Assurance review and approval of Event notifications.
- Possess and understanding of cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600.
- Perform oversight and inspections of active production areas to resolve problems and to ensure compliance with SOPs and policies.
- Perform general oversight of Buildings 1 and 2 (including cold rooms/freezers) and their associated activities, as required.
- Review and release of Plasma pools to manufacturing.
- Review all manufacturing support documentation (logbooks, log sheets, charts, etc.)
- Perform review and release of raw materials in LIMS/SAP.
- Perform audits of Nitrogen receipt process.
- Assist with quarantining and release of critical systems, equipment, and controlled environments.
- Rotation amongst QA Specialists to provide 24/7 manufacturing oversight coverage. Required to work 12-hour shifts (07:00 AM to 07:00 PM or 07:00 PM to 07:00 AM). Must be available to support coverage on either shift.
- Assist in other oversight activities, as needed.
- Coordinate and perform any additional activities or projects assigned by QA Management.
- Experience with LIMS and SAP is preferred.
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