Quality Assurance Specialist - Warrington Pennsylvania

Company: Polysciences, Inc.
Location: Warrington, Pennsylvania
Posted On: 04/18/2024

Who We Are Ott Scientific - The Ott Scientific family of companies comprises Polysciences, Bangs Laboratories, and Ethos Biosciences. Together, we deliver innovative chemistries, products and services that support advancements in highly specialized industries such as medical device, diagnostics, bioprocessing, fine chemicals and technology. Polysciences - In Polysciences 60 years of operation, we've grown into a nexus of technical operations and scientific laboratories housing custom synthesis, contract manufacturing and packaging and laboratory products. Through these three divisions, we are proud to offer a broad range of products and tailored solutions for the life sciences, bioprocessing, microparticles, medical device, specialty chemical and eChem industries. We adhere to ISO13485:2016, FDA cGMP 21 CFR 820 regulations, and SOCMA's ChemStewards Management System. We believe the best scientific innovations are built through collaborations. At Polysciences, we take chemistry beyond the ordinary. We produce and sell specialty chemicals for several industries including pharmaceuticals, electronics, academic research and personal care. We need driven, detail-oriented team players to support our growing operations and customer base, and identify further opportunities for growth. We're looking for a Quality Assurance Specialist to safely execute directives of the Quality Assurance Department that incorporate our core competencies to achieve the stated responsibilities in support of the company objectives. RESPONSIBILITIES: Oversee daily operational activities and ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures.

• 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. More...

      

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