Quality Assurance Associate
4 weeks ago
We are seeking a Quality Assurance Associate to provide on-the-floor oversight and support to our Manufacturing Operations team. This is a 12-month contract opportunity.
Shift Options: Alternate Wed, Thurs-Sat 1800-0700 or Alternate Wed, Sun-Tues 1800-0700
Key Responsibilities:
- Review executed batch records and associated documents to ensure compliance with approved procedures and cGMP expectations.
- Respond to quality-related incidents or non-conformances on the floor and secure necessary documentation for real-time investigations.
- Represent QA in support of deviations, including active participation in Root Cause Analysis.
- Provide cGMP and compliance guidance to Manufacturing and Technical Services personnel.
- Provide QA support, including authoring, review, and approval of documents in Quality Management Systems.
- Perform area walkthroughs.
Qualifications:
- Bachelor's degree in a scientific discipline.
- 3-5 years of experience in a biologics manufacturing environment.
- Prior batch record execution or review experience.
- Prior experience in investigation, change control, and other Quality Management Systems (QMS).
- Working knowledge of cGMPs.
- Manufacturing and Manufacturing Sciences experience preferred.
R&D Partners is a national staffing firm focused on Scientific, Clinical Research, and Engineering. Our team offers over 200 years of combined staffing experience, providing consulting, direct hire, and outsourcing solutions.
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