Quality Specialist I
About The Position
Element Materials Technology currently has an opening for a Quality Specialist I to join our growing team in Concord, CA. The Concord laboratory specializes in pharmaceutical and life sciences testing services, supporting developers and manufacturers with microbiology, virology, environmental monitoring, analytical chemistry, sterility, and rapid sterility testing solutions. The site is FDA and DEA registered, cGMP certified, and ISO/IEC 17025:2017 accredited. The Quality Specialist I is responsible for ensuring laboratory services remain compliant with the Quality Manual, client requirements, and applicable regulatory standards. This role plays a key part in supporting the laboratory’s pharmaceutical quality and compliance operations while helping maintain the integrity, accuracy, and reliability of testing services provided to clients. Primary responsibilities include monitoring the effectiveness of the Quality Management System (QMS), supporting internal compliance initiatives, assisting with audits and quality investigations, and helping implement continuous improvement activities. The Quality Specialist I also provides guidance, training, and quality support to laboratory personnel to ensure adherence to regulatory and client requirements in a highly regulated GMP environment. This position is ideal for candidates interested in supporting pharmaceutical quality systems within a fast-paced laboratory environment focused on patient safety, regulatory compliance, and operational excellence.
Requirements
- A B.S. in science is desired with typically 0-2 years of pharmaceutical/biotechnology/GMP industry experience.
- Handles routine matters and problems.
- Follows company and regulatory quality standards.
- Basic knowledge of industry and governmental quality regulations.
- Audits and reviews quality data according to existing procedures.
- Involved in root cause investigations.
- Excellent time management and prioritization, strong interpersonal skills, attention to detail, plans tasks to meet deadlines, good critical thinking skills, and demonstrates Element Values.
Responsibilities
- Comply to and enforce data integrity requirements(21 CFR Part 11, 210, and 211)
- Maintain QA files and training matrixes
- Review Certificates of Analysis, raw data files, in-house documentation, and logbooks
- Scan data and files records
- Submit data and Certificates to clients
- Document management and archival
- Release Media and Reagents
- Initiate and participate in quality event investigations using eQMS MasterControl
- Support client Audits
- Other duties as assigned
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
