Responsibilities:
- Supervise and organize Lab Analysts and other lab employees; oversee day-to-day operations with regular shop-floor presence.
- Oversee chemical analysis and release of raw materials, in-process, and final products in compliance with quality criteria; manage deadlines and costs.
- Lead and develop a high-performing team (hiring, performance expectations, feedback, coaching, problem-solving, and employee matters); monitor and administer training.
- Oversee laboratory operations for raw materials, finished products, projects/validation samples, MEC, and stability samples; organize work by planning demands.
- Control products by following analysis and equipment qualification procedures to meet the testing schedule.
- Identify test/result issues requiring attention; implement corrective actions.
- Review and approve analytical data (may support product release depending on regional requirements).
- Support investigations, including out-of-specification results, and ensure effective corrective actions.
- Communicate and present QC metrics; attend and lead Tier meetings.
- Ensure QC activities follow internal procedures, cGMP, and safety standards; support continuous improvement.
- Assist with analytical/microbial instrumentation; ensure availability through preventive/repair maintenance and material qualifications; apply corrective actions to prevent instrumentation failures.
- Support laboratory facility inspections for GMP/GxP readiness and audits (supplier/internal/regulatory as needed).
- Serve as backup to Lab Manager; generate/manage hazardous and non-hazardous waste per procedures and local/federal regulations.
Qualifications:
- Bachelorβs degree required (preferably Chemistry, Microbiology, or Biology).
- 2+ years of QC lab experience.
- Strong scientific knowledge and expertise in chemistry, technical writing, investigations, analytical equipment, and lab operations.
- Knowledge of cGMPs, compendia, and regulations.
- Strong problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution; ability to foster an inclusive environment.
- Ability to work cross-functionally and interpret lab data to take appropriate actions.
- Ability to develop, communicate, and complete corrective action plans.
Benefits (if applicable/explicitly stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, 401(k) to eligible employees.
- Eligible for short-term incentive programs.