Sr. Quality Assurance Specialist

Job 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.