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- 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.
- 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.
- 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.
Quality Assurance Specialist - Morrisville, United States - Ehub Global Inc
Description
Position: Quality Assurance Specialist
Location: 101 Southcenter Court, 27560 Morrisville, NC
Contract
Requirements:
Responsibilities:
Skills: