Chemist C Job Durham area,North Carolina USA,Quality Assurance

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.

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

Knowledge of EMPOWER Chromatography Data System and LIMS
QC experience in Generic Pharmaceutical industries would be preferable
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

Perform other duties as assigned

BS or MS in Chemistry or Pharmaceutical Sciences, or related field
Minimum 5+ years of experience in Pharmaceuticals and Analytical testing is desirable
Preference shall be given for experience in Inhalation testing on a variety of Inhalation products