Quality Control Specialist II
2 weeks ago
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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