Associate II, Quality Assurance

1 month ago

Norwood, United States Randstad Life Sciences US Full time

There are 4 shifts available below in the body of this message.

The fastest way to get considered is to email me your resume to my work email and your top 2 shift choices to my email: michael.anderson@randstadusa.com


Also still apply here on the LI postin I have as a back-up...


Randstad Life Sciences has several contract openings onsite with a pharmaceutical in Norwood, MA. MUST work onsite, this is mandatory b/c you’re doing onsite batch paper record reviews. The pay rates are also locked in with no flexibility so please know that if you decide to apply.


Also when you email me your resume, please tell me which shifts you are interested or available for, PLEASE try and pick 2 different shifts to have a backup one.


Title: Associate II, Quality Assurance (Onsite Contract)

Shift: 1st Shift: 7:00am-5:00pm, WED-SAT ($39.35 - 5% shift differential included)

Shift: 1st Shift: 7:00am-5:00pm, SUN-WED ($39.35 - 5% shift differential included)

Shift: 2nd Shift: 12:00pm-10:00pm, WED-SAT ($40.65 - 15% shift differential included)

Shift: 2nd Shift: 12:00pm-10:00pm, SUN – WED ($40.65 - 15% shift differential included)


Contract Duration: 4 Months – until end of December 2024 as of now….

  • All of these positions will be going through December, as of now.
  • This position is primarily paper record review.
  • Should have experience with batch record review.
  • GMP background within manufacturing is a plus.
  • Minimum experience should be 6 months - 3+ years.
  • This is 100% on-site in Norwood, MA working onsite – no exceptions, there is no remote work in these roles offered.


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.

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