QA Specialist 2, Batch Release Contractor

Job description

The QA Specialist 2 provides essential Quality Assurance support to Quality Operations, with a primary focus on material and batch release activities. Working within established GMP processes and under moderate supervision, this role contributes to maintaining compliance with Good Manufacturing Practices (GMP) and current Good Manufacturing Practices (cGxP) regulations. The successful candidate applies developing professional knowledge, strong attention to detail, and effective communication skills to support documentation, compliance monitoring, and quality system activities in a fast-paced pharmaceutical environment. Key Responsibilities: GMP Database & Documentation Support: - Maintain accurate and consistent tracking, data entry, and follow-up within departmental GMP databases under established procedures - Prepare and conduct initial reviews of batch and material release documentation, ensuring conformance with applicable SOPs, specifications, and acceptance criteria - Evaluate completed manufacturing, filling, labeling records, and analytical data for compliance with regulatory standards and company requirements; escalate discrepancies to senior QA staff - Report key quality...