What are the responsibilities and job description for the QA Specialist position at TalentBurst, an Inc 5000 company?
Title: QA Specialist
Location: Morrisville, NC
Duration: 6+ Months
Location: Morrisville, NC
Duration: 6+ Months
- 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:
- Working within our ERP system (Slingshot) to ensure compliant material release.
- Acquiring Certificates from Vendors to support Release per Master Specification.
- Reviewing 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.
- Upon release, archiving the completed Mater Specification within document control room.
- Proactively assess and identify risk for mitigation and communication to stakeholders.
- Responsible for completing assigned training and other tasks in a timely manner and representing Quality in meetings and providing meeting feedback to the team as required.
- As required, advise and provide quality oversight and compliance guidance based on the company procedures and standards for the SMPA Quality Management System.
- Responsible for completing the logbook and Work Order reviews for Manufacturing, Engineering, Quality, and Warehouse to ensure that the entries are complete and adhere to company policies and procedures.
- This role will be 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.
- Responsible for providing 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.
- B.S. in chemistry, biological or pharmaceutical sciences, or related discipline
- At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
- 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.
