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Quality Assurance Specialist
2 months ago
We are seeking a highly motivated and detail-oriented Quality Associate II to join our team at Omni Inclusive. This role plays a critical part in supporting the cGMP quality operations for our Bothell Manufacturing Plant. The successful candidate will be responsible for reviewing cGMP Controlled Documents, conducting quality walk-throughs, and ensuring product and processes meet cGMP and internal standards.
Key Responsibilities- Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with manufacturing operators or supervisors.
- Conduct quality on the floor activities, including quality walk-throughs of production, testing, and warehouse locations.
- Execute quality operations in support of manufacturing and logistics.
- Provide quality support to manufacturing personnel on the floor, provide guidance during GMP events, and initiate deviation investigations.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch-related deviations.
- Oversee manufacturing operations during patient material receipt and drug product pack out.
- May participate in revisions of Standard Operating Procedures as needed.
- Bachelor's degree in a relevant science or engineering discipline is preferred. Minimum of Associate degree and/or equivalent combination of education and experience is required.
- 2-3 years of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing are preferred.
- Hands-on experience with batch record review and product disposition is preferred.
- Strong computer skills with Word and Excel and other electronic manufacturing systems.
- Detail-oriented team player with effective planning, organization, time management, and execution skills.
- Proven experience working on teams where combined contribution, collaboration, and results were expected.
- Must exercise accurate judgment and be able to evaluate information critically and decide upon appropriate course of action.
- Ability to work in a high-paced team environment.
- Strong written and verbal skills.
The employee is frequently required to stand, walk, sit, bend, stretch, use hands and fingers, with various manipulations, reach with hands and arms, and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings. May work in areas with strong magnets, vapor phase liquid nitrogen, and other chemicals. Must be able to gown per requirements to enter manufacturing space and wear personal protective equipment (PPE) and other clean room garments daily.
