Analytical Chemist I
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Role Overview
The Chemist I is an entry-level professional responsible for performing routine analytical testing in support of OTC manufacturing operations. This role works under direct supervision and follows established procedures to ensure laboratory testing is conducted in compliance with cGMP, USP, FDA, and company quality standards.
Responsibilities
- Perform routine analytical testing of raw materials, in-process samples, stability samples, and finished OTC products according to approved methods
- The testing may include, but is not limited to: HPLC/GC, IR, UV, wet chemistry, Auto-titrator, etc., for raw materials, bulk liquids, and finished products
- Accurately document test results in appropriate laboratory notebooks, worksheets, logs, or other designated forms in compliance with cGMP requirements
- Operate basic laboratory instrumentation, including pH meters, balances, pipettes, UV-Vis, FTIR, and titration equipment
- Follow approved SOPs, test methods, compendial testing, and safety procedures at all times.
- Notify supervisor of atypical results or laboratory issues
- Participate in training to develop proficiency in chromatographic techniques (HPLC and/or GC)
- Perform testing and review of raw materials, in-process samples, and finished products to adhere to required timeframes
Required Skills and Work Experience
- Associate or bachelor’s degree in chemistry, Analytical Chemistry, or other related field
- 1-2 years of laboratory experience (GMP experience preferred but not required)
- Basic understanding of chemistry principles and analytical techniques
- Familiarity with GMP concepts preferred
- Strong attention to detail and documentation accuracy
- Ability to follow detailed written procedures
- Good organizational and time management skills
- Basic proficiency with the Microsoft Suite
- Good interpersonal skills that support working in a team environment