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- Responsible for implementing and maintaining the effectiveness of the quality system.
- Manage the direct activities of an area within a department or function.
- Ensures that compliance is maintained and that employees are trained and following the required site level policies and procedures.
- Review, revise and approve (GMP QA) SOPs, protocols/batch records, reports, and other quality and regulated records involving technically complex issues and processes for accuracy and compliance with all applicable regulations and internal policies.
- Participate in the preparation and review of QA files in preparation for site visits and regulatory inspections; assure that QA audit files are retained.
- Participate in client site visits and regulatory inspections.
- Management of a Customer Complaint system that can lead teams to customer-oriented and compliant solutions.
- Management of Nonconformance, CAPA, OOS systems.
- Perform internal audits to assess that records are attributable, legible, contemporaneous, original, accurate, and in compliance with regulations, international standards, SOPs, protocols/batch records, and corporate policies and procedures as needed to support departmental workload.
- Assure the suitability of materials and supplies for compliance with specifications.
- Review and approve all procedures related to production and maintenance, approving or rejecting incoming materials, in-process materials and finished product.
- Provide regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
Quality Assurance Specialist - Warrington, United States - Polysciences, Inc.
Polysciences, Inc.
Warrington, United States
3 weeks ago