What are the responsibilities and job description for the QA Specialist position at Sunrise Systems, Inc.?
Job Title : QA Specialist
Job ID : 25-06155
Location : Morrisville, NC
Duration : 12 Month's Contract on W2
Duties :
This role is not remote. The role will require presence onsite at the Morrisville location and on 2-2-3 shift to support GMP operations. This is an alternating shift that includes weekends on a rotating basis, as the manufacturing process is a 7-day a week process.
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, advice 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 :
Education :
Skills and Experience :
Required Skills :
Additional Skills :
Languages :
English (Read, Write, Speak)
Certifications & Licenses :
Acquiring Certificates from Vendors to support Release per Master Specification
