Job Title: QA Shop Floor Specialist
Job Duration: 6 Months (potential for conversion based on performance)
Job Location: Devens, MA 01434
Night Shift: Tuesday-Saturday, 8hrs/day shifts (6 PM – 2 AM, Night Shift)

Role Overview:
Client is seeking a Contractor Field QA Specialist for the QA Operations organization at the Cell Therapy Facility (CTF) in Devens, MA.  
The Contractor Field QA Specialist is responsible for quality activities for the Cell Therapy Facility in accordance with the company's policies, standards, procedures, and Global cGMP.
Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations to resolve manufacturing issues.  
Reports to the Head of QA Field for the Devens CTF.

Responsibilities:

• Execution of label control tasks and logbook management.
• Floor operations (70-80% of their shift will be on the floor).
• Apheresis-related tasks.
• Gowning and working in compliance with GMP standards.

Requirements:

• Experience:
  • 2-3+ years of MFG experience (mgrs are looking for someone with experience)
  • Experience with label control, MES (Manufacturing Execution Systems), and SAP is NOT Required but would be gladly welcomed. 
  • Prior GMP gowning experience (Grade 8 gowning minimum requirement).
• Digital Proficiency:
  • Syncade, SAP, Veeva, Trackwise, electronic batch records, DeltaV, LIMS, Lab Notebooks are all pluses. 

Training:

• The first three weeks will be training on day shifts (Monday-Thursday Normal Hours)
  • Topics include gowning, MES, SAP, Label QA, GPS, and Polestry.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.