Quality Assurance Specialist (Morrisville) Job at Hornet Staffing, Inc, a GEE Group company, Morrisville, NC

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  • Hornet Staffing, Inc, a GEE Group company
  • Morrisville, NC

Job Description

Description:

  • 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:
  • Supporting incoming material release activities within the ERP system, ensuring compliance with applicable regulations and internal procedures.
  • Obtaining Certificates of Analysis (CoA), Certificates of Compliance (CoC), and other required documentation from vendors in alignment with the Master Specification.
  • Reviewing and verifying all incoming documentation to confirm that materials meet defined testing specifications and quality standards.
  • Coordinating with cross-functional teams to ensure proper disposition of released or rejected materials, including timely transfer to designated storage or quarantine areas.
  • Archiving finalized Master Specifications and associated release documentation in the document control room, maintaining accurate and organized records.
  • Proactively assess potential risks and implement mitigation strategies, ensuring timely communication with relevant stakeholders.
  • Complete assigned training and tasks within required timelines, represent the Quality function in cross-functional meetings, and provide feedback to the team as needed.
  • Provide quality oversight and compliance guidance in accordance with company procedures and standards outlined in the SMPA Quality Management System.
  • Conduct thorough reviews of logbooks and Work Orders across Manufacturing, Engineering, Quality, and Warehouse departments to ensure entries are complete, accurate, and compliant with company policies and procedures.
  • 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.
  • Complete additional tasks and responsibilities as assigned by the manager in a timely and professional manner.
  • This role is an on-site position, scheduled Monday through Friday, primarily supporting GMP operations. The standard working hours are from 8:00 AM to 4:00 PM; however, flexibility may be required based on business needs.

Qualifications :

  • 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, SAP, Blue Mountain RAM and VEEVA is preferred.

Job Tags

Part time, Work experience placement, Monday to Friday, Flexible hours,

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