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Quality Assurance Specialist - Quality Engineering - Contract

  • Location: Boston
  • Salary: US$60 - US$65 per hour per hour
  • Job Type:Contract

Posted 29 days ago

Our leading pharmaceutical client is hiring for a Quality Specialist / Quality Assurance Engineer. The role is an initial 6-Month contract with potential to extend or move to permanent. Take a look at a short description below and apply with your most up-to-date CV.

GENERAL POSITION SUMMARY:

The Quality Specialist - QA Engineering is knowledgeable in the principles and application of quality assurance and compliance. The Quality Specialist supports or executes daily activities related to equipment or instrumentation supporting Facilities, Utilities, Manufacturing, and Labs. The Quality Specialist supports multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

DESIRED EDUCATION AND EXPERIENCE:

  • Demonstrated success independently leading cross-functional teams
  • Experience providing QA support and oversight of GMP manufacturing operation
  • Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting:
    • cGMP's and associated CMC regulatory considerations
    • experience with continuous manufacturing a plus
  • Experience with equipment, facilities and utility system qualifications activities in a cGMP setting, including change controls
  • Experience with event investigations, Root Cause Analysis (RCA), and CAPA
  • Experience with Oracle and Veeva Quality Systems preferred.
  • B.S in scientific or allied health field (or equivalent degree) and 3+years of relevant work experience

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