What are the responsibilities and job description for the QA Specialist position at Paladin Consulting?
QA Specialist (Shifts)
- 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.
Qualifications :
