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Sr QA Associate I/II
2 months ago
Overview Applicants invited to apply for Senior QA Associate I/II role in Quality assurance department. Reporting in the first instance to the QA Manager of Sterile Operations, the successful candidate will have the key responsibilities as outlined below. Responsibilities Ensures compliance to internal procedures, policies, and standards, as well as all relevant State, Federal and International regulations during oversight of the operations. Approve complaints, change controls, deviations, CAPA, batch records, validation reports and other controlled documents Identifies compliance risks and develops sound rationale as basis for audit observations. Supports the coordination activities and assists with interactions during regulatory agency inspections Perform internal audits. Participates in the review and revision of Compliance-related controlled documents *Skills / Qualifications * 6-8 years' experience in the pharmaceutical quality function for a Sr. QA Associate I 8+ years' experience in the pharmaceutical quality function for a Sr. QA Associate II Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements Experience in quality systems for drug product manufacturing and quality control operations Experience in Pharmaceutical aseptic operations Project management experience including scheduling, tracking and auditing Technical expertise and understanding of cGMP sterile filling manufacturing processes Strong problem analysis (root cause analysis, risk assessment, and CAPA development) skills are preferred Experience in document and change control review/ approval and auditing Familiarity with Validation documentation, qualification of facilities, utilities, equipment and processes Ability to effectively plan, organize and prioritize work Education Bachelor's degree in a scientific discipline or related field #LI-Hybrid LI-RS1
