Quality Specialist I

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 laboratorys 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.

Pay Range: $30$34/hour DOE
Site Status: 100% On-Site (no exceptions)

Site Page: EMT Concord

• 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

• 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.

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At Element we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming the worlds most trusted testing partner.

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age disability ethnic origin gender marital status race religion responsibility of dependents sexual orientation or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)

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