Senior Analytical Chemist — GMP QC & Methods

Aurobindo Pharma USA, Inc.; Durham (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Aurolife seeks a Chemist B to perform routine analytical testing and wet laboratory work, maintaining GLP in the lab. You will handle sampling, testing, data recording, and documentation under GMP, focusing on raw materials through finished products.

Requirements include a BS in a scientific field with 3-5 years pharma experience and 2-4 years in analytical testing, plus knowledge of USP/ICH/FDA and Good Documentation practices. Opportunity to grow in a quality-focused environment.

Qualifications

• Minimum BS with Scientific field
• BS with Chemistry is one of the subjects would be preferable
• Minimum 3-5 years experience in pharmaceuticals and must have 2-4 year experience in Analytical testing
• Experience in Generic Pharmaceutical industries would be preferable
• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
• Ability to learn quickly and decision making skills .

Responsibilities

• Perform assigned sampling, physical, chemical tests and assay 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/equipments 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

Skills

Analytical testing

Education

BS in scientific field

Tools

HPLC

GC

UV-Vis

IR

Particle Size Analyzer

KF Auto titrator

Bulk Density

Job description

Aurolife seeks a Chemist B to perform routine analytical testing and wet laboratory work, maintaining GLP in the lab. You will handle sampling, testing, data recording, and documentation under GMP, focusing on raw materials through finished products.

Requirements include a BS in a scientific field with 3-5 years pharma experience and 2-4 years in analytical testing, plus knowledge of USP/ICH/FDA and Good Documentation practices. Opportunity to grow in a quality-focused environment.