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QA Specialist

Morrisville, NC 27560

Posted: 01/28/2025 Employment Type: Contract Job Category: Quality and Compliance Job Number: 617411 Is job remote?: No Country: United States

Job Description

Target Pay Rate: 30-34.60/hr **salary will be commensurate with experience 

Job 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:
  • 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.
    Certifications:
    • Acquiring Certificates from Vendors to support Release per Master Specification
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    About Morrisville, NC

    Ready to take the next step in your career? Explore our job opportunities in the vibrant area surrounding Morrisville, North Carolina! Nestled in the heart of the Research Triangle Park, this region offers an exceptional blend of bustling tech hubs, picturesque green spaces like Lake Crabtree County Park, and a lively cultural scene boasting the North Carolina Museum of Art and the Duke Energy Center for the Performing Arts. Indulge in the area's diverse culinary scene, catch a game at the PNC Arena, home to the Carolina Hurricanes, or simply relax at Umstead State Park. Embrace the charm and endless growth opportunities that Morrisville and its surroundings have to offer - your dream job could be just a click away!

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