Quality Specialist I

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 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.

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

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

Skills / Qualifications

• A B.S. in science is desired with typically 0-2 years of pharmaceutical/biotechnology/GMP industry experience.
• 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.

Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Diversity Statement

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 world's 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 contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

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