Quality Assurance Specialist

Quality Assurance Specialist needs 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.

Quality Assurance Specialist requires:

8a-4p

cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.

Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry

Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs.

Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.

Working experience in KNEAT, SlingShot, SAP, Blue Mountain RAM and VEEVA is preferred.

M-F, onsite

Quality Assurance Specialist duties:

Provide Quality and Compliance oversight for manufacturing of commercial and investigational products through Shop Floor presence.

Responsible for performing inspection and disposition of raw materials and components by: Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.

Obtain Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.

Review and verify all incoming documentation to confirm that materials meet defined testing specifications and quality standards.

Coordinate with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.

Archive finalized Master Specifications and associated release documentation in the document control room, maintaining accurate and organized records.

Proactively assess potential risks and implement mitigation strategies, ensuring timely communication with relevant stakeholders.