Quality Assurance Specialist
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Role & Company Overview
📋 Role Overview & Responsibilities
Position: Quality Assurance Specialist Location: Morrisville, NC (Onsite)Type: Contract
Requirements:Bachelor's degree in chemistry, biological sciences, pharmaceutical sciences, or related discipline. Minimum 3 years of Quality experience in the biotech/pharmaceutical industry. Experience in cGMP manufacturing environment with knowledge of FDA requirements. Familiarity with ERP systems (Slingshot), KNEAT, Blue Mountain RAM, and VEEVA preferred. Strong understanding of GMP standards and SOPs. Responsibilities:Review and disposition of raw materials and components. Ensure compliant material release using ERP system. Obtain certificates from vendors to support release per Master Specification. Review documentation (CoA, CoC, CoS, etc.) to ensure compliance with testing specifications. Coordinate transfer of rejected or released materials to appropriate areas. Archive completed Master Specifications within document control room. Complete logbook reviews in KNEAT for Manufacturing, Quality, and Warehouse. Review and disposition of completed Manufacturing batch records. Complete assigned trainings and tasks in a timely manner. Represent Quality in meetings and provide feedback to the team. Communicate Quality issues and risks to management and stakeholders. Assist in risk mitigation efforts. Maintain inspection readiness at manufacturing facility.
Skills:Experience in cGMP manufacturing environment. Strong knowledge of FDA requirements and guidance documents. Experience with ERP systems (Slingshot), KNEAT, Blue Mountain RAM, and VEEVA preferred. Familiarity with manufacturing processes, batch record review, and analytical analyses in biotech/pharmaceutical industry.
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