Chemistry Analyst I

Stokes Pharmacy•Mount Laurel Township, NJ

4h•Onsite

About The Position

The Chemistry Analyst I supports cGMP analytical chemistry analysis for routine testing, stability testing, and method transfer. The position performs and reviews analytical testing, supports investigations, authors and revises procedures and reports, maintains laboratory organization and inventory, and assists with equipment qualification and calibration. Testing must meet applicable GxP, cGMP, USP, ICH, FDA, and company standards. The role operates primarily in a controlled GxP laboratory and requires use of standard office equipment and frequent standing and walking. Employees must be able to wear required protective equipment and handle laboratory machinery and chemicals safely. This is a full-time position; work schedules may vary. No travel is expected.

Requirements

Bachelor's degree in Chemistry or a relevant field.
3–10 years of experience with HPLC/UPLC analysis.
Familiarity with general laboratory instrumentation and equipment, including Karl Fischer, micropipettes, pH meters, analytical balances, vortex mixers, centrifuges, and volumetric glassware.
Familiarity with GMP, FDA, ICH, and OSHA requirements.
Experience using MS Word, Excel, and/or relevant applications.
Ability to wear required protective equipment, including masks, gloves, gowns, respirators, and safety goggles.
Ability to work with small, delicate machinery and complete analyses in a timely manner.
Ability to work safely with chemicals used in sample analysis, including acids, bases, and solvents, following required precautions.
Strong organizational skills and exceptional attention to detail.
Punctuality and low absenteeism.
Ability to work independently and as part of a team.
Ability to sit, stand, squat, kneel, reach, and walk for prolonged periods.
Ability to lift 25–50 pounds, as needed.

Nice To Haves

Experience using Empower 3 software.

Responsibilities

Independently perform analytical testing of finished products, research and development materials, stability samples, and raw materials.
Ensure testing is performed in accordance with cGMP, USP, ICH, FDA, GxP, and company standards.
Review and approve analytical testing data.
Assist with investigations.
Author and revise SOPs, protocols, and data reports.
Maintain laboratory organization and inventory.
Assist with qualification and calibration of equipment.
Develop knowledge of FDA regulatory expectations for departmental development.