5 дней назад
Manager III, Quality Control (Chemistry Lab)
139 000 - 173 000$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manager III, Quality Control (Chemistry Lab) (Pharmaceutical Manufacturing): Leading a GMP-regulated chemistry laboratory responsible for product testing, quality systems, regulatory compliance, and team performance with an accent on FDA requirements, LabWare LIMS, and laboratory process improvement. Focus on root cause investigations, CAPA, cross-functional quality issue resolution, and maintaining compliance across manufacturing and laboratory operations.
Location: Irvine, California, United States; onsite
Salary: $139,000–$173,000 per year
Company
develops, manufactures, and markets medical products and services for infusion therapy, pain management, nutrition, pharmacy compounding, wound care, ostomy care, and dialysis.
What you will do
- Lead the Quality Control Chemistry Laboratory team and oversee daily laboratory operations, testing activities, and employee performance.
- Ensure compliance with FDA regulations, including 21 CFR Parts 210, 211, and 820, GMP, QMS, and other applicable requirements.
- Oversee laboratory testing, product inspections, investigations, documentation, and quality processes.
- Develop and improve quality control programs, testing methods, and laboratory processes.
- Lead root cause investigations, CAPA, and continuous improvement initiatives.
- Collaborate with Manufacturing, Quality Assurance, Regulatory Affairs, and Technical Services while managing metrics, priorities, and budgets.
Requirements
- Bachelor’s degree in chemistry, chemical engineering, biochemistry, or a related scientific field.
- 10+ years of quality control, quality assurance, or related experience.
- Extensive experience leading Quality Control laboratories in pharmaceutical, medical device, or regulated manufacturing environments.
- Strong knowledge of LabWare LIMS, GMP regulations, and quality systems.
- Experience with USP, Health Canada, and European Medicines Agency testing standards and methods.
- Leadership experience managing large teams across multiple shifts; occasional business travel is required.
Nice to have
- Master’s degree.
- Valid driver’s license and passport.
Culture & Benefits
- Work across office, manufacturing, laboratory, and warehouse settings.
- Healthcare benefits and a 401(k) plan.
- Tuition reimbursement.
- Culture focused on knowledge sharing, continuous improvement, safety, accountability, and sustainability.
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