Quality Supervisor

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 laboratory's 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

Responsibilities

• 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

Skills / Qualifications