Chemist B

Job Description

Job Summary:

• Chemist B is responsible for ensuring that products and materials meet established quality standards and regulatory requirements by conducting laboratory tests, analyzing results, and maintaining accurate documentation.
• They perform testing on raw materials, in-process samples, and finished goods using various analytical techniques, while adhering to standard operating procedures (SOPs), Standard test procedure and Good Manufacturing Practices (GMP).
• QC Analysts also investigate discrepancies such as out-of-specification results, support corrective actions, maintain laboratory equipment, and ensure compliance with regulatory guidelines.
• This role requires strong attention to detail, technical expertise, and the ability to work in regulated environments.

Duties and Responsibilities:

• Perform physical, chemical and instrumental tests on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
• Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
• Independently plan and execute testing to meet established time lines.
• Perform complicated testing with supervisory direction.
• Record data and results as specified in documentation procedures.
• Document work clearly and perform tests accurately.
• Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
• Perform maintenance and calibrations of laboratory instruments/equipment’s with supervisory direction/ training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• Review of Analytical documents as required.

Required Qualifications:

• Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing.
• Knowledge in Good Documentation practices.
• Knowledge in USP/ICH/FDA.
• Ability to learn quickly and decision making skills.
• Minimum BS with Scientific field.

Preferred Qualifications:

• BS with Chemistry is one of the subjects preferred.
• Experience in Generic Pharmaceutical industries would be preferable