What are the responsibilities and job description for the QA Specialist position at Advanced Clinical?
Location: Morrisville, NC
Duration: 3 months
Hours: Full-time, 40 hours/week
Position Overview
We are seeking a QA Specialist to provide quality and compliance oversight for the manufacturing of both commercial and investigational products. This role requires a strong presence on the shop floor and close collaboration with cross-functional teams to ensure compliance with cGMP regulations, FDA requirements, and internal quality standards. The QA Specialist will play a key role in supporting material inspection and disposition, reviewing batch records, and maintaining documentation control.
Key Responsibilities
Duration: 3 months
Hours: Full-time, 40 hours/week
Position Overview
We are seeking a QA Specialist to provide quality and compliance oversight for the manufacturing of both commercial and investigational products. This role requires a strong presence on the shop floor and close collaboration with cross-functional teams to ensure compliance with cGMP regulations, FDA requirements, and internal quality standards. The QA Specialist will play a key role in supporting material inspection and disposition, reviewing batch records, and maintaining documentation control.
Key Responsibilities
- Provide Quality and Compliance oversight for GMP operations through shop floor presence.
- Inspect and disposition raw materials and components in accordance with regulations and internal procedures.
- Support incoming material release activities within the ERP system.
- Obtain and verify Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required vendor documentation against Master Specifications.
- Review incoming documentation to confirm compliance with defined specifications and standards.
- Collaborate with cross-functional teams to ensure proper disposition and storage/quarantine of materials.
- Archive Master Specifications and release documentation in the document control system.
- Proactively identify risks and implement mitigation strategies with timely stakeholder communication.
- Provide quality oversight and guidance in accordance with the Quality Management System.
- Review logbooks and work orders across Manufacturing, Engineering, Quality, and Warehouse departments for accuracy and compliance.
- Perform QA review/approval of completed Manufacturing batch records in a timely manner.
- Complete assigned training, participate in cross-functional meetings, and provide quality feedback as needed.
- Perform additional tasks and responsibilities as assigned.
- B.S. degree in Chemistry, Biological Sciences, Pharmaceutical Sciences, or related field.
- Minimum 3 years of experience in the biotech/pharmaceutical industry within R&D or commercial operations.
- Hands-on experience in a cGMP manufacturing environment with solid knowledge of FDA requirements and guidance documents.
- Strong background in manufacturing processes, batch record review, and/or analytical analyses.
- Experience with electronic systems such as KNEAT, SlingShot, SAP, Blue Mountain RAM, and VEEVA (preferred).
- Excellent organizational skills with the ability to manage multiple projects under tight timelines.
- Demonstrated integrity, ownership mentality, and commitment to excellence.
- Flexible team player, able to adapt to changing business needs and take on additional responsibilities.
