Chemist A

Overview:
The Chemist 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 the 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/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

Qualification:

• QC experience in the generic pharmaceutical industry is preferable
• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
• Ability to learn quickly and strong decision making skills

Education:

• Minimum BS within an applicable scientific field
• BS in Chemistry preferable
• Minimum 1-3 years experience in pharmaceuticals and 1-2 years experience in analytical testing desirable