Chemist

Chemist (Full time)

Location: Durham, NC

Shift Time: Mon - Fri 1st shift

Job Description:

Basic Summary: Chemist A will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level.

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/equipment 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.

Minimum 2-3 years experience in pharmaceuticals and 1-2 year experience in Analytical testing desirable

• QC 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.

Other duties as assigned

• Minimum BS with Scientific field.
• BS with Chemistry is one of the subjects preferred.