Alphanumeric is hiring a QA SPECIALIST - Level 2 to work in Upper Merion, King of Prussia, PA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
Pay Range: $55 - $61
Quality support of Validation and Qualification Activities, such as:
- Ensure compliance with Good Manufacturing Practices (GMP) and other regulatory guidelines in the validation and qualification of processes, equipment, and facilities.
- New Product Introduction (NPI): Provide quality oversight and approval of technology transfer activities to ensure adherence with the company and regulatory standards. This includes review and approval of various tech transfer related protocols, tasks, and documentation.
- Review and approve validation protocols for facility services, utilities, equipment, and computer systems, at all phases of the validation lifecycle, including cleaning validation.
- Support PAI and regulatory inspections, as well as internal inspections and routine.
- Provide quality oversight of routine facility/utility spaces including housekeeping Gemba.
- Other duties as required to support manufacturing, right first time tech transfer, and Operational Quality as needed.
Education: Bachelor degree with scientific area of focus.
Minimum Years of Experience: 2 years.