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Sr. Quality Assurance Specialist
Location:
Warrington, PA
Description:
Polysciences technical operations and scientific laboratories offer custom synthesis, contract manufacturing and packaging, and laboratory products. 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. 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 daily quality activities of a business unit as it relates to the QMS. Ensures that compliance is maintained and that employees are trained and following the required site level policies and procedures as it applies to a specific business unit. Drive process improvements by partnering with cross functional stakeholders. Review, revise, and approve 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 for site visits and regulatory inspections; assure that QA audit files are retained. Participate in client site visits and regulatory inspections. Management of a Change Control system that can lead teams to customer-oriented and compliant solutions. Working knowledge and application of root cause tools as they relate to Nonconformance, CAPA, and 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, approve and/or reject or rejecting incoming materials, in-process materials and finished product. Perform all other related duties as assigned.
Company:
Polysciences
Posted:
May 8 on TopUSAJobs
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More About this Listing: Sr. Quality Assurance Specialist
Sr. Quality Assurance Specialist is a Quality Assurance QA Specialist Job at Polysciences located in Warrington PA. Find other listings like Sr. Quality Assurance Specialist by searching Oodle for Quality Assurance QA Specialist Jobs.
Sr. Quality Assurance Specialist is a Quality Assurance QA Specialist Job at Polysciences located in Warrington PA. Find other listings like Sr. Quality Assurance Specialist by searching Oodle for Quality Assurance QA Specialist Jobs.