Quality Control Specialist II

2 weeks ago


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

Available Shifts:

We have multiple shifts available for this role, and we encourage you to indicate your preferences when applying.

Position Overview:

Randstad Life Sciences is seeking qualified candidates for several contract positions in the field of Quality Assurance. This role requires on-site presence for essential batch record evaluations. The compensation rates are fixed, so please consider this when applying.

Role Summary:

The Quality Assurance Associate II is an integral member of a dedicated team that ensures compliance with cGMP standards for mRNA drug products. This position focuses on delivering quality oversight and expertise, ensuring adherence to a robust Quality System that meets global regulatory standards. The role involves collaboration with various departments, including Quality Control, Manufacturing, and Logistics.

Key Responsibilities:

  • Conduct comprehensive reviews of Master Batch Records (MBR) and electronic Batch Records (eBR), working closely with the manufacturing team to ensure prompt documentation finalization.
  • Perform quality assessments and approvals for essential documents supporting GMP operations, including protocols, forms, and reports.
  • Review and certify archived GMP documents.
  • Utilize 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.
  • Complete required training as per the defined learning plan and requalification schedule.
  • Collaborate with cross-functional teams to address documentation challenges and promote continuous improvement initiatives.

Qualifications:

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


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