Demo

QA Specialist

TalentBurst
Morrisville, NC Full Time
POSTED ON 2/8/2025
AVAILABLE BEFORE 5/2/2025

QA Specialist

Morrisville, NC

12 Months

This role is not remote. The role will require presence onsite at the Morrisville location and on 2-2-3 shift to support GMP operations. This is an alternating shift that includes weekends on a rotating basis, as the manufacturing process is a 7-day a week process.

  • 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.
  • Skills :

  • 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.
  • Education :

  • 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.
  • TB_PH

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