Quality Supervisor

Element has a current opening for a Quality Supervisor to join our growing team in Santa Fe Springs CA.

The Quality Supervisor is responsible for overseeing the day-to-day QA operations within a GMP-regulated pharmaceutical environment ensuring full compliance with applicable regulations client requirements and internal quality standards. Acting as a key link between the laboratory teams and the Quality Manager this role ensures that all testing activities are executed with accuracy efficiency and in alignment with established procedures.

Serving as the bridge between the laboratory operations and Quality leadership the Quality Supervisor facilitates effective communication coordinates priorities and ensures that quality expectations are clearly understood and consistently met across all functional areas. This includes timely review of analytical data oversight of documentation management of laboratory investigations such as deviations Out of Specifications and CAPAs and preparation for client and regulatory audits. The Quality Supervisor not only ensures that the lab is audit-ready at all times but also drives continuous improvement initiatives fostering a proactive quality culture. This includes implementing corrective and preventive actions (CAPAs) monitoring their effectiveness and embedding lessons learned into SOPs and workflows to prevent recurrence.

The position demands both technical expertise and strong leadership skills to guide the QA team in supporting multiple labs resolving operational quality issues promptly and driving continuous improvement initiatives. The Quality Supervisor will play a pivotal role in maintaining audit readiness reinforcing a culture of compliance and ensuring that the laboratorys output meets the highest scientific and regulatory standards. The role requires a deep understanding of GMP ISO 17025 FDA and ICH requirements as well as the ability to apply these standards to real-world laboratory scenarios.

$85k-$105k DOE

• Oversee day-to-day QA operations ensuring timely and compliant review of data reports and Quality Assurance Data Packages generation.
• Act as the primary liaison between laboratory staff and the Quality Manager to ensure alignment on priorities and deliverables
• Supervise QA personnel assigning tasks monitoring performance and providing training and mentorship
• Collaborate review and approve SOPs test methods validation protocols equipment qualifications calibrations verifications and related documentation
• Coordinate and support internal client and regulatory audits ensuring readiness and managing follow-up actions
• Lead and support investigations into deviations OOS/OOT results and client complaints ensuring thorough root cause analysis and effective CAPA implementation
• Monitor compliance with GMP GDP ISO 17025 and client-specific requirements
• Facilitate effective cross-departmental communication to resolve quality issues and remove workflow barriers
• Promote and implement continuous improvement initiatives to enhance operational efficiency and regulatory compliance
• Support the implementation and monitoring of eQMS activities
• Performs other related duties as assigned

• Bachelors degree in Chemistry Biology Pharmaceutical Sciences or a related discipline (advanced degree preferred)
• Minimum 5 years of experience in a GMP-regulated pharmaceutical or contract laboratory with at least 2 years in a supervisory QA role
• Strong knowledge of GMP ISO 17025 FDA EMA and ICH guidelines
• Experience in reviewing analytical data method validations and technical reports
• Proficiency with Quality Management Systems (QMS) LIMS and electronic document control systems
• Strong leadership coaching and team management skills
• Excellent communication and interpersonal abilities to effectively bridge technical and management teams
• Strong problem-solving skills with the ability to make sound timely decisions in a fast-paced environment
• Detail-oriented with a commitment to accuracy compliance and data integrity
• Excellent organizational skills and attention to detail
• Ability to function well in a high-paced and at times a stressful environment
• Proficient with Microsoft Office Suite related software

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Element is one of the fastest growing testing inspection and certification businesses in the world. Globally we have more than 9000 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.

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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