Sr Quality Assurance Specialist

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.