Senior Lab Chemist: GMP-Analytical Specialist

Great HealthWorks

Town of Florida (NY)

On-site

USD 65,000 - 85,000

Full time

6 days ago
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Job summary

Great HealthWorks is seeking a Lab Chemist II to perform routine and moderately complex analytical testing of raw materials, in-process materials, stability samples, and finished dietary supplement products. The role requires adherence to 21 CFR Part 111, cGMP, SOPs, GDP, and data integrity practices.

You will operate instruments including HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution equipment, prepare reagents, review results, and participate in investigations and CAPA initiatives with

Qualifications

  • Minimum BA/BS degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
  • Minimum 3–5 years of laboratory experience within GMP-regulated environments preferred.
  • Experience with analytical testing methods such as HPLC, GC, UV-Vis, FTIR, dissolution.
  • Experience with microbiological testing, environmental monitoring, or water testing preferred.
  • Experience working in a cGMP-regulated laboratory with SOPs and test methods.

Responsibilities

  • Perform routine and moderately complex analytical testing using techniques including HPLC, GC, UV-Vis, FTIR, and dissolution.
  • Test raw materials, in-process materials, stability samples, and finished products per specifications.
  • Prepare standards, reagents, and solutions for testing.
  • Operate laboratory instrumentation such as HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution equipment.
  • Troubleshoot instruments and ensure calibration and maintenance of equipment.
  • Review results against specifications and communicate OOS/OOT or atypical results.
  • Participate in investigations, CAPA, and data review with QA.
  • Maintain accurate, contemporaneous laboratory records and supporting documentation.
  • Assist with training and support internal audits and regulatory inspections.

Skills

cGMP knowledge
Good Documentation Practices
Analytical chemistry
Instrumentation operation
Data integrity
Communication skills
Problem-solving
Independent work

Education

BA/BS in Chemistry or related field

Tools

LIMS
Microsoft Excel

Job description

Great HealthWorks is seeking a Lab Chemist II to perform routine and moderately complex analytical testing of raw materials, in-process materials, stability samples, and finished dietary supplement products. The role requires adherence to 21 CFR Part 111, cGMP, SOPs, GDP, and data integrity practices.

You will operate instruments including HPLC, GC, UV-Vis, FTIR, Karl Fischer, and dissolution equipment, prepare reagents, review results, and participate in investigations and CAPA initiatives with

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