QA Specialist

The Fountain Group is currently seeking a Quality Assurance Specialist for a prominent client of ours. This position is located in Morrisville, NC. Details for the position are as follows:

Shift Details:

• The role will require presence onsite at the Morrisville location and on a 2-2-3 shift to support GMP operations (2 days on, 2 days off, 3 days on, 2 days off, so on).
• This is an alternating shift that includes weekends on a rotating basis, as the manufacturing process is a 7-day a week process.
• Working Hours: Sunday-Thursday 7am-7:30pm + Friday-Saturday 7am-5:30pm.

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 Master 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.
• 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.

Qualifications:

• BS or MS in a life science
• 3+ years biotech/pharma industry experience
• Strong GMP/FDA experience
• Skills in batch record review
• Quality oversight experience
• Raw material inspection & disposition
• Experience in CoA / CoC / CoS
• Preferred Software: VEEVA, KNEAT, SAP, SlingShot, Blue Mountain Ram

Compensation: $28-35 per hour depending on experience