Chemist C

Job Description

Job Summary:

• QC Chemist C will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials.
• Will work as a member of the stability team to effectively execute QC analytical testing using established (official and/or in-house) test procedures.
• This role will entail 80% – 100% of their work being performed at the bench level.
• The Chemist C will be responsible for review of analytical documents , investigations, maintain the GLP status in lab.

Duties and Responsibilities:

• Perform assigned in-process, finished product and stability product testing, using various wet chemicals, physical and instrumental techniques ( HPLC, UPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per Finished Product methods.
• Independently plan and execute testing to meet established time-lines.
• Perform complicated testing with little supervisory direction.
• Assist with the preparation or review of Test Procedures, SOPs, Protocols, and CoAs as assigned.
• Record data and results as specified in documentation procedures.
• Document work clearly and perform tests accurately.
• Perform maintenance and calibrations of laboratory instruments/equipment with little supervisory direction/training.
• Perform troubleshooting and investigations under the direction of a supervisor.
• Assist in drafting deviation reports as assigned.
• 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
• Investigation for OOS/OOT/Deviation and other lab related events.

Required Qualifications:

• BS or MS in Chemistry or Pharmaceutical Sciences, or related field.
• Minimum 5+ years of experience in Pharmaceuticals and Analytical testing is desirable.
• Knowledge of EMPOWER Chromatography Data System and LIMS.
• Experience in a cGMP environment is required.
• Knowledge and use of Good Documentation practices.
• Knowledge of USP/ICH/FDA guidelines.
• Team player who will assist junior colleagues.
• Willing to work flexible hours to meet product deliverables.
• Ability to learn quickly and have decision making skills that adhere to regulatory practices is required.

Preferred Qualifications:

• Preference shall be given for experience in Inhalation testing on a variety of Inhalation products.
• QC experience in Generic Pharmaceutical industries would be preferable.