Chemist B

Job Description

Job Summary:

• The Chemist B will be responsible for sampling, testing, and analysis of raw materials, in-process materials, finished products, and stability samples in accordance with approved specifications, analytical methods, and regulatory requirements.
• The role involves operating and maintaining analytical instruments, reviewing and documenting analytical data, supporting laboratory investigations, and ensuring compliance with cGMP, cGLP, Data Integrity, and laboratory safety requirements.
• The position also contributes to the timely release of materials and products while maintaining high standards of quality and accuracy.

Duties & Responsibilities:

• Perform sampling and routine/advanced physical, chemical, and instrumental analyses of raw materials, APIs, in-process samples, finished products, cleaning validation samples, and stability samples.
• Operate analytical instruments such as HPLC, GC, UV-Visible Spectrophotometer, FTIR, Particle Size Analyzer, Karl Fischer Auto Titrator, Bulk Density Apparatus, and other QC laboratory equipment.
• Independently plan, organize, and prioritize daily laboratory activities to ensure timely completion of assigned testing.
• Prepare, standardize, and maintain adequate inventories of reagents, volumetric solutions, reference standards, and laboratory consumables.
• Perform routine analytical testing independently and support complex analyses under the guidance of senior staff or supervisors.
• Ensure timely reporting of analytical results and promptly communicate atypical findings to the supervisor.
• Accurately document raw data, calculations, observations, and test results in controlled laboratory records and electronic systems.
• Ensure compliance with Good Documentation Practices (GDP) and ALCOA+ Data Integrity principles.
• Prepare, revise, and review analytical test procedures, SOPs, specifications, protocols, reports, and other laboratory documents as assigned.
• Perform routine calibration, verification, maintenance, and qualification activities for laboratory instruments as per approved procedures.
• Maintain instrument logbooks and ensure laboratory equipment remains in a qualified and compliant state.
• Participate in laboratory investigations related to Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, atypical results, and laboratory incidents.
• Assist in troubleshooting analytical methods, instruments, and testing-related issues under supervisory guidance.
• Support the implementation of Corrective and Preventive Actions (CAPA).
• Perform technical reviews of analytical data, laboratory notebooks, worksheets, chromatograms, calculations, and associated documentation.
• Verify compliance with approved analytical methods, specifications, and documentation requirements before reporting results.

Qualifications & Experience:

• Minimum 3–5 years of experience in the pharmaceutical industry, including 2–4 years of experience in analytical testing.
• Bachelor’s degree (BS) in a scientific discipline is required.
• A degree with Chemistry as one of the subjects is preferred.
• Experience in the generic pharmaceutical industry is preferred.
• Knowledge of Good Documentation Practices (GDP), USP, ICH guidelines, and applicable FDA requirements.
• Ability to learn quickly and demonstrate sound decision-making skills.
• Good analytical, troubleshooting, documentation, and time-management skills.