Quality Assurance Specialist - The Fountain Group
Morrisville, NC
About the Job
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:
Job Description:
Job Description:
- 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.
- Responsible for completing the logbook review in KNEAT for Manufacturing, Quality, and Warehouse to ensure that the entries are complete and adhere to company policies and procedures.
- Responsible for reviewing and dispositioning of the completed Manufacturing batch records in a timely manner and ensure that the entries adhere to the company policies and procedures.
- Responsible for completing assigned trainings and other tasks in a timely manner and representing Quality in meetings and providing meeting feedback to the team as required.
- Communicate any Quality issues and risks to management and stakeholders in a timely manner and assist in risk mitigation.
- Ensure a state of inspection readiness at the manufacturing facility by completing tasks on time, and adhering to regulatory guidelines, company policies and procedures.
- BS in a life science
- Quality/GMP experience within biotech/pharma
- Batch Record Review
- Logbook Review
- Material Release
- PREFERRED: KNEAT | Slingshot | Blue Mountain RAM | VEEVA
Source : The Fountain Group