What are the responsibilities and job description for the QA Specialist position at Sunrise Systems, Inc.?
Job Details
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:
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:
- Experience in a cGMP manufacturing environment, with strong working knowledge of FDA requirements and guidance documents.
- Relevant experience and knowledge of manufacturing, batch record review, and/or analytical analyses for the biotech/pharmaceutical industry.
- Integrity, entrepreneurial spirit, ownership mentality, and a commitment to excellence.
- Be flexible and contribute positively to the team's success, take on additional tasks as required and adjust to changing business needs.
- Strong organizational skills and ability to work on multiple projects with tight timelines and minimal oversight.
- Working experience in KNEAT, SlingShot, Blue Mountain RAM and VEEVA is preferred.
Education:
- Minimum Degree Required: Bachelor's Degree
- B.S. in chemistry, biological or pharmaceutical sciences, or related discipline
- At least 3 years of experience in the biotech/pharmaceutical industry within research and development or commercial organizations.
Skills and Experience: Required Skills:
- QA
- BATCH RECORD REVIEW
- BATCH RECORDS
- SHOP FLOOR
- CGMP
Additional Skills:
- BIOTECH/PHARMACEUTICAL
- ORGANIZATIONAL SKILLS
- ERP
- ENTERPRISE RESOURCE PLANNING
- MITIGATION
- CHEMISTRY
- DOCUMENT CONTROL
- QMS
- CONTROL ROOM
- ARCHIVING
- OPERATIONS
- FDA
- GMP
- DOCUMENTATION
- MANUFACTURING PROCESS
Languages:
English (Read, Write, Speak)
Certifications & Licenses:
Acquiring Certificates from Vendors to support Release per Master Specification
English (Read, Write, Speak)
Certifications & Licenses:
Acquiring Certificates from Vendors to support Release per Master Specification
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