1 день назад
Quality Control Supervisor-Analytical (Night Shift)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Quality Control Supervisor-Analytical (Night Shift) (cGMP/Pharmaceutical Quality): Supervising analytical quality control operations, stability studies, testing schedules, and laboratory documentation for drug products with an accent on regulatory compliance, data analysis, and team leadership. Focus on troubleshooting assay and instrumentation issues, reducing deviations through continuous improvement, and executing CAPA plans to support manufacturing demands.
Location: Portsmouth, New Hampshire, United States
Night shift: Monday–Friday, 8:00 p.m.–4:30 a.m.
Company
operates more than 30 sites across five continents and manufactures medicines and life-science products for customers.
What you will do
- Supervise analytical quality control operations, including scheduling and on-time delivery of routine testing under cGMP and regulatory requirements.
- Organize stability studies and ensure timely results that support manufacturing needs.
- Create, review, and approve QC documentation while improving laboratory management systems and reducing deviations.
- Lead projects, continuous improvement initiatives, new process implementation, and OE initiatives.
- Troubleshoot assay and instrumentation issues using data mining, trending, and analysis.
- Hire, mentor, and develop staff; resolve personnel issues; support audits and create and execute CAPA plans.
Requirements
- Bachelor’s degree in a scientific field; Microbiology or Biochemistry is preferred.
- 5–10 years of cGMP experience and at least 2 years of direct supervisory experience, with equivalent combinations of education and experience considered.
- Experience with applicable laboratory software and hardware systems.
- Experience using GMP quality systems such as TrackWise, LIMS, DMS, and electronic laboratory notebooks.
- Ability to prioritize workload, solve complex problems, share knowledge, and support analyst development.
Culture & Benefits
- Inclusive, ethical, and collaborative working culture.
- Competitive salary, performance-based bonuses, and compensation programs.
- 401(k) matching plan.
- Medical, dental, and vision insurance.
- Career development opportunities and access to global benefits.
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