OverviewElement has a current opening for a
Senior Quality Specialist to join our growing team in Concord, CA). The
Senior Quality Specialist's main duties are to ensure services are compliant to the Quality Manual, client requirements and regulatory requirements as applicable such as; ISO 17025:2017, USP, CGMP, FDA and ICH guidelines at Element Concord.
The
Senior Quality Specialist aims to ensure that the service that is provided is fit for its purpose and meets customer expectations. The main responsibility is to ensure compliance with customer requirements and GMP regulations, as well as monitors the performance of the quality management system. Where appropriate, advises on changes and their implementation and provides training, tools and techniques to enable others to achieve quality.
Site Status: 100% On-Site
Pay Range: $85k-$95k DOE
Responsibilities- Responsible for ensuring the integrity of all data and documentation reported from the laboratory - routine reports, method verifications, validations, equipment qualifications, etc.
- Reviews all source data and associated documentation for accuracy and CGMP conformance.
- Supports in the preparation and collation of training material and other relevant quality related activities.
- Ensure compliance with the vendor qualification process.
- Assist in the investigations. Review and approve deviations, change controls, CAPAs, and OOS reports to assure complete compliant source data.
- Manages proficiency testing program for maintenance of ISO 17025 accreditation.
- Perform internal audits and assist with client audits.
- Supporting the team to ensure calibrations, facilities / equipment qualifications and verifications, and materials receipt are being managed and are up to date.
- Verify laboratory testing is conducted in accordance with SOPs as well as compendial (USP/NF, EU) and ISO 17025:2017 regulations.
- Other duties as required and appropriate to support the quality function.
Skills / Qualifications- A B.S. in science is desired with typically 6-8 years of pharmaceutical/biotechnology/GMP industry experience. Work is highly independent. Handles complex matters and problems autonomously, both routine and non-routine in nature.
- Confirms site regulatory quality standards adhere to Business Unit requirements. Advanced knowledge of industry and governmental quality regulations. Understands how to interpret whether procedures are followed correctly. Regularly runs root cause investigations and trends RCA data.
- Excellent time management and prioritization, strong interpersonal skills, attention to detail, plans tasks to meet deadlines, good critical thinking skills, and role models Element Values (Integrity, Care, and Progress).
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