Quality Assurance Associate II

2 weeks ago


Norwood, Massachusetts, United States Randstad Life Sciences US Full time

Shift Availability:

We have multiple shifts available for this position, which will be detailed below.

Position Overview:

Randstad Life Sciences is seeking qualified candidates for several contract roles in Quality Assurance. This position requires on-site work, as it involves the review of critical documentation related to batch records. Please note that the pay rates are fixed and non-negotiable.

Available Shifts:

  • 1st Shift: 7:00 AM - 5:00 PM, Wednesday to Saturday
  • 1st Shift: 7:00 AM - 5:00 PM, Sunday to Wednesday
  • 2nd Shift: 12:00 PM - 10:00 PM, Wednesday to Saturday
  • 2nd Shift: 12:00 PM - 10:00 PM, Sunday to Wednesday

Contract Duration:

This role is expected to last for several months, with a focus on paper record review.

Key Responsibilities:

  • Conduct comprehensive reviews of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating with the manufacturing team to ensure timely documentation finalization.
  • Perform quality assessments and approvals for essential documents supporting GMP operations, including protocols, forms, and reports.
  • Review and certify scanned copies of GMP documents for archiving purposes.
  • Utilize various GxP systems to identify and resolve gating actions affecting product disposition.
  • Maintain accurate data within GxP and non-GxP systems to support the Quality Assurance Disposition team.
  • Adhere to all relevant GxP regulations, guidelines, and company policies to ensure compliance with both regulatory and internal standards.
  • Complete required training as per the defined learning plan and requalification schedule.
  • Work collaboratively with cross-functional teams to address documentation challenges and support continuous improvement initiatives.

Qualifications:

  • Bachelor's Degree in a relevant field.
  • 1-3 years of experience in the biotechnology or biopharmaceutical industry, preferably in Quality Assurance or document control.
  • Familiarity with quality systems, particularly batch record review processes.


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