QA Compliance Lead - Afternoons

Job Title: QA Compliance Lead – Afternoons (2:00 p.m. to 10:30 p.m.) Location: Pomona, CA (In-office) Position Type: Full-time, Vacancy Status: This position is vacant AI Disclosure in Hiring: We use artificial intelligence to screen, assess and select applicants Purpose of the Position/ Role Summary 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. Key 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. Additional Notes Working conditions: warehouse and production environments. Exposure to noise, chemicals and machinery. PPE required in certain areas. Physical demands: Walking, standing, occasional lifting (up to 50 pounds). May require work outside regular hours or weekends. Competencies Required for the Role Effective communication: conveying information clearly, listening, and facilitating information sharing between people while using data and facts to support understanding and respect in interactions. Fostering collaboration/teamwork: working jointly with others, leading teams, and building partnerships for global performance while respecting others. Analytical thinking/problem solving: identifying needed information, seeking it from various sources, and tackling problems using a logical, systematic, sequential approach. Ability to spot patterns and trends and deduce cause and effect. Results orientation: focusing on desired results, setting challenging goals, and meeting or exceeding them. Qualifications & Experience 5–7 years in pharmaceutical QA / GMP environment Strong experience in: Batch record review & product release Deviation investigations & CAPA systems 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 What We Offer Health Insurance (medical, dental, vision) 401(k) plan for retirement savings Paid time off (vacation, sick leave, holidays) Life insurance Employee assistance program Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. #J-18808-Ljbffr Bimeda, Inc.