JOB DESCRIPTION
Job Title
Analytical Chemist/Bio Chemist in Generic Prescription Pharmaceuticals
Grade
chemist/biochemist
Reporting To
Team Lead
Location
Chantilly, VA
Purpose
The role of QC Biochemist/Chemist II is responsible for supporting the operations and manufacturing process by performing routine and non-routine analytical testing raw materials, in-process, finished formulations, stability samples, method development and/or transfers, and cleaning validations. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Responsible for the safe and efficient execution of job duties.
Responsibilities
- Conduct routine analytical/microbiological testing of raw materials, packaging materials, finished product release and stability using approved methods and various instrumentation while adhering to cGMP and established policies.
- Conduct analytical USP method verifications, validations, and method transfer activities for raw materials and finished dosage forms.
- Perform the Calibration, Qualification, Preventive maintenance, and routine trouble shooting of analytical instruments like UPLC, HPLC, GC, UV spectrophotometer, Dissolution apparatus, KF Auto titrator, FT-IRS spectrophotometer, Polarimeter and Refractometer.
- Compile laboratory test data and perform appropriate analyses that include physical (solubility, viscosity), chemical (titration) and analytical (FTIR, HPLC, ICP-MS, UV-Vis, KF, IC) testing etc.
- Complete documentation needed to support testing procedures including test forms and logbooks.
- Interpret test results, compare them to established specifications and control limits, and ensure appropriateness of data for release. Treats data with a high level of integrity and ethics.
- Participate in out-of-specification and failure investigations. Support all aspects of laboratory investigations.
- Prepare, review, and approve analytical data, technical reports, and analytical methods.
- Coordinate Microbiological, preservative efficacy/ antimicrobial effectiveness testing requirement as per USP/USP-NF for Active pharmaceutical ingredients, Inactive and Finished products and stability samples for regulatory filings.
- Any other activity as assigned by the Supervisor.
Qualifications and Experience
- BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Biotechnology or related field. Five (5) plus years of experience in using analytical instrument techniques (HPLC/GC/FT-IR, UV-Vis, Dissolution Apparatus, Ovens/Auto Titrators/KF Titrator/Particle size analyzers/ Ion-Chromatography, etc.).
