QA Specialist

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.