Barrington James | Quality Assurance Specialist
7 days ago
Job Responsibilities:
- The QA Specialist will review and approve batch records, ensuring completeness and compliance with cGMP requirements.
- Conduct reviews of manufacturing and laboratory documentation for accuracy and adherence to quality standards.
- You will support the investigation and resolution of deviations, out-of-specifications (OOS), and customer complaints, including root cause analysis and implementation of corrective actions.
- Assist in internal and external audits, including supplier audits, to verify compliance with regulatory and company standards.
- Monitor compliance with cGMP regulations and quality policies throughout the organization.
- Author, review, and revise Standard Operating Procedures (SOPs) to align with current regulatory and operational requirements.
- Provide assistance during customer and regulatory agency inspections.
- Support vendor audits and maintain supplier-related quality documentation.
Job Requirements
- Bachelor’s Degree in Life Sciences, Chemistry, or a related field.
- Minimum of 3+ years of experience in a Quality Assurance role within the pharmaceutical, biotechnology, or related industry.
- Strong understanding of cGMP, regulatory standards (e.g., FDA, ICH), and quality systems.
- Experience with document review, investigations, and quality system processes (e.g., change controls, CAPA).
- Familiarity with FSMS or food safety principles is a plus.
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