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

QA Specialist requires:

• Experience in a 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. Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.

• 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, Blue Mountain RAM and VEEVA is preferred.

• On site and on 2-2-3 shift to support GMP operations alternating shifts that include weekends on a rotating basis, as the manufacturing process is a 7-day a week process.

QA Specialist duties:

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

• Perform inspection and disposition of raw materials and components by: Work within our ERP system (Slingshot) to ensure compliant material release. Acquiring Certificates from Vendors to support Release per Master Specification.

• Review the required documentation (CoA, CoC, CoS, etc.) to ensure that the material meets testing specification.

• Ensure rejected and or released materials are transferred to the appropriate areas by collaborating with appropriate stakeholders.

• Provide QA review/approval of the completed Manufacturing batch records in a timely manner and ensuring that the entries adhere to the company policies and procedures.