Role OverviewLead analytical laboratory and quality control operations in an FDA-regulated manufacturing environment, overseeing testing, laboratory compliance, method validation, investigations, and quality control programs.
What You Will Do
Perform and review analytical testing, lead laboratory investigations, manage method validation, supervise laboratory personnel, and ensure compliance with FDA regulations and company quality standards.
Why It Might Be a Fit
The ideal candidate is a hands-on laboratory leader with extensive experience in analytical chemistry and a strong background in FDA-regulated manufacturing, with expertise in analytical instrumentation, method validation, laboratory investigations, and quality control systems.
Requirements
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
- Minimum of 5 years of hands-on analytical chemistry laboratory experience in a GMP-regulated manufacturing environment.
- Previous management or supervisory experience leading a laboratory team.
- Strong knowledge of FDA regulations, cGMP, GLP, GDP, and laboratory quality systems.
- Experience with HPLC, GC, FTIR, UV-Vis, and other analytical instrumentation.
- Experience with method validation, verification, transfer, and stability testing programs.
- Experience conducting OOS, OOT, deviation, CAPA, and root cause investigations.
- Strong technical writing, analytical, organizational, and problem-solving skills.
Benefits
- Paid Vacation
- Medical Insurance with 80% coverage for employees and 20% for dependents
- Dental and vision insurance
- Short-term Disability
- Voluntary Life Insurance
- Company-paid life insurance
- 401(k) plan with company-matching
- Weekly pay
- ZayZoon - gives you instant access to your wages ahead of payday
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