QA Compliance Lead

Job Title: QA Compliance Lead - Afternoons (2:00p.m. to 10:30p.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

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.

• 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 when 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.

• 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 working outside regular hours or weekends.

EFFECTIVE COMMUNICATION: Ability to convey information to another effectively and efficiently, to listen and facilitate sharing of information between people. About understanding the emotional intention behind information. Communicating clearly in conversations, confirming understanding, communicating using data and facts. Willingness to listen and show respect.

FOSTERING COLLABORATION/TEAMWORK: Ability to work jointly with others, especially in an intellectual endeavor; ability and desire to work cooperatively with others on a team; leading a team, demonstrating interest, skill, and success in learning to work together. Builds partnerships for global performance. Respects others.

ANALYTICAL THINKING/PROBLEM SOLVING: Ability to identify the information needed to clarify a situation, seek that information from various sources, and tackle a problem by using a logical, systematic, sequential approach. Identify and separate key components, interpret information from a range of sources to spot patterns and trends, deduce cause and effect.

RESULTS ORIENTATION: Ability to focus on the desired result of one’s own department’s work, setting challenging goals, focusing on those goals, and meeting or exceeding them.

• 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

• 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 identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.