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QA Associate II

1 month ago

Norwood, United States Randstad Life Sciences US Full time

4 Month Contract - NO EXTENSIONS

Norwood, MA

PR: $32-40/hour

Shifts:

1st Shift: 7:00am-5:00pm, SUN-WED

OR

1st Shift: 7:00am-5:00pm, WED-SAT

OR

2nd Shift: 12:00pm-10:00pm, SUN - WED

OR

2nd Shift: 12:00pm-10:00pm, WED-SAT

Job Summary

The Quality Assurance Associate II / Specialist is part of a cohesive team responsible for supporting cGMP mRNA drug products produced internally.. The main responsibility for this position is to provide quality oversight and expertise to enable technical success with stringent adherence to a Quality System that respects global regulatory expectations. This role interacts fluidly with peers and supervisors in Quality Assurance, and cross-functionally with Quality Control, Manufacturing, Logistics and Manufacturing Science & Technology counterparts.


Job Responsibilities

  • Conduct thorough review of Master Batch Records (MBR) and electronic Batch Records (eBR), collaborating closely with the manufacturing team to ensure timely finalization of documentation.
  • Perform quality review / approval for documents aside from batch records that are required to support GMP operations such as protocols, forms, and reports.
  • Review and certify scanned copies of GMP documents submitted for archive.
  • Perform queries in various GxP systems to identify and alleviate gating actions for product disposition.
  • Maintain data within GxP and non-GxP systems to support the Quality Assurance Disposition team.
  • Follows all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
  • Completes training in assigned required learning plan according to the defined timing and the prescribed requalification cadence.
  • Collaborate with cross-functional teams to resolve documentation issues and support continuous improvement initiatives.


Education & Qualifications

  • Bachelors Degree
  • 1-3 Years experience in the biotechnology/biopharmaceutical industry, or other regulated industry. Preferably in Quality Assurance and/or Training / document control.
  • Experience with quality systems, including batch record review.
  • Proficiency in authoring and reviewing GMP documentation.