QA Compliance Lead - Afternoons

Bimeda•Pomona, CA

11d•$75,000 - $100,000•Onsite

About The Position

The QA Compliance Lead is the senior-most QA Compliance resource supporting manufacturing operations and serves as the primary day-to-day quality lead. This role ensures consistent execution of cGMP compliance activities, including batch record review, deviation investigations, CAPA oversight, and audit readiness. The Lead acts as a key partner to the QA Manager by driving quality processes, supporting regulatory readiness, and providing guidance to QA Compliance Associates.

Requirements

5–7 years in pharmaceutical QA / GMP environment
Strong experience in: Batch record review & product release
Strong experience in: Deviation investigations & CAPA systems
Strong experience in: Audit support (FDA/customer)
Demonstrated ability to work independently and make quality-based decisions
Strong technical writing and documentation skills
Proven ability to coach others without formal authority

Nice To Haves

Effective communication skills, including the ability to convey information clearly, listen actively, and use data and facts.
Fostering collaboration and teamwork, including the ability to work jointly with others and build partnerships.
Analytical thinking and problem-solving skills, including the ability to identify information, seek it from various sources, and tackle problems logically.
Results orientation, including the ability to focus on desired results, set challenging goals, and meet or exceed them.

Responsibilities

Own day-to-day QA compliance activities across manufacturing, ensuring timely batch review and product release in accordance with GMP standards.
QA oversight of manufacturing, including label control and issuance and in-process inspections.
Lead deviation investigations, OOS events, and non-conformances, including root cause analysis and CAPA development.
Review and approve QA documentation (batch records, deviations, CAPAs) prior to QA Manager escalation where required.
Serve as primary QA contact on the floor, providing real-time guidance to Associates, operators, and supervisors.
Conduct and support internal audits to ensure adherence to SOPs, cGMP, and regulatory requirements.
Support regulatory inspections and customer audits, including preparation, hosting support, and follow-up actions.
Monitor QA systems and quality trends, escalating risks and recommending improvements.
Support SOP and document updates to maintain compliance and operational efficiency.
Coach and mentor QA Compliance Associates on investigations, documentation, and GMP expectations.
Partner cross-functionally with Operations, QC, and other teams to drive a culture of quality and compliance.