Quality Assurance Specialist

Pay ranges between: $20-27/hr and is based on expereince  
Duties:    
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.
Skills:    
Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
At least 3 years of Quality experience in the biotech/pharmaceutical industry within research and development or commercial organizations is required.
Working experience in KNEAT, SlingShot, Blue Mountain RAM and VEEVA is preferred.
Relevant experience and knowledge of manufacturing, batch record review, incoming material release, logbook review and/or analytical analyses for the biotech/pharmaceutical industry.
Education:    
B.S. in chemistry, biological or pharmaceutical sciences, or related discipline is required.