Quality Specialist I

Overview

Element has a current opening for a Quality Specialist I to join our growing team in Santa Fe Springs, CA. The Quality Specialist I supports the Quality Assurance function by performing routine QA activities to ensure compliance with applicable regulatory requirements (e.g., FDA 21 CFR Part 11, 210/211, ISO 17025) and internal quality standards. This entry-level position assists with reviewing analytical data packages, monitoring compliance in laboratory activities, equipment and method qualifications review and approval, and document control. Reports to the Quality Supervisor and/or Quality Manager.

$25hr-$35hr DOE

Responsibilities

• Perform QA review of analytical data packages, logbooks, notebooks, and laboratory reports for completeness, accuracy, and compliance with client requirements and regulatory expectations.
• Support timely issuance, revision, and control of SOPs, test methods, protocols, and logbooks through the document control system.
• Assist in the documentation and tracking of deviations, events, and non-conformances.
• Support QA Audit Walk-throughs to observe laboratory practices and verify compliance with Good Documentation Practices (GDP) and cGMP.
• Participate in QA review of equipment qualification and method validation documentation prepared by technical staff.
• Ensure that controlled records are archived and retained according to company procedures and regulatory expectations.
• Collaborate with Laboratory Operations, Client Services, and other departments to support client audits, regulatory inspections, and internal continuous improvement efforts.

Skills / Qualifications

• Bachelor’s degree in Chemistry, Biology, Pharmaceutical Sciences, or related field.
• 0–2 years of quality assurance or laboratory experience in a GMP-regulated environment (internships or academic lab work may be considered).
• Familiarity with FDA and ICH guidelines applicable to pharmaceutical testing, particularly 21 CFR Parts 210, 211, and 11.
• High attention to detail and commitment to data integrity and accuracy.
• Strong written and verbal communication skills.
• Ability to prioritize tasks and meet deadlines in a fast-paced, client-driven environment.
• Ability to collaborate with colleagues and work effectively as part of a team
• Experience in a pharmaceutical or analytical contract laboratory setting.
• Familiarity with electronic quality systems (e.g., MasterControl, Veeva, TrackWise) and LIMS.
• Working knowledge of method validation, equipment qualification, or raw data traceability principles.

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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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