Analytical Chemist

Job Title: Analytical Chemist

Location: Durham, NC

Duration: Full Time

Job Description:

• The QC Chemist will perform various quality control (QC) tests to evaluate the strength, identity, purity, and quality of raw materials, active pharmaceutical ingredients (APIs), in-process materials, finished products, and stability samples.
• The role involves planning and executing analytical testing using established official, compendial, and in-house test procedures.
• The position is primarily laboratory-based and requires hands-on experience with analytical instruments and routine QC activities.

Key Responsibilities

• Perform sampling and physical, chemical, and assay testing of raw materials, APIs, in-process materials, finished products, and stability samples as per USP, in-house, and other applicable compendial methods.
• Operate analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, IR, Particle Size Analyzer, Karl Fischer (KF) Titrator, and Bulk Density Tester.
• Plan and maintain adequate inventory of laboratory reagents, solutions, and consumables, ensuring timely availability of supplies.
• Independently plan and execute analytical testing to meet established timelines, performing complex tests under supervisory guidance.
• Record analytical data and results accurately in accordance with established documentation procedures and Good Documentation Practices (GDP).
• Prepare and/or review test procedures, Standard Operating Procedures (SOPs), and protocols as assigned.
• Perform laboratory instrument maintenance and calibration under supervisory guidance or after appropriate training.
• Assist in troubleshooting, laboratory investigations, and related activities under the direction of a supervisor.
• Ensure compliance with applicable regulatory and internal requirements, including cGMP, cGLP, laboratory safety, housekeeping, chemical waste management, and documentation practices.
• Review analytical documents and records as required.

Qualifications and Experience

• Bachelor's degree (BS/B.Sc.) in a scientific discipline; a degree with Chemistry as one of the subjects is preferred.
• 1–3 years of experience in the pharmaceutical industry.
• 1–2 years of experience in analytical testing is desirable.
• Experience in Quality Control (QC), preferably in the generic pharmaceutical industry.
• Knowledge of Good Documentation Practices (GDP), USP, ICH guidelines, and applicable FDA requirements.
• Ability to learn quickly, troubleshoot routine issues, and make sound decisions.
• Good analytical, documentation, and time-management skills.