Sr. Quality Assurance Specialist
Company: Polysciences, Inc.
Location: Warrington
Posted on: May 8, 2024
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.
Keywords: Polysciences, Inc., Cherry Hill , Sr. Quality Assurance Specialist, Professions , Warrington, New Jersey
Didn't find what you're looking for? Search again!
Loading more jobs...