In a Pharmaceutical Manufacturing laboratory, the QC Chemist is primarily responsible for the daily HPLC sample preparation and testing in the QC lab as well as other testing that may be required including GC, UV-VIS, etc. This role is also responsible for analyzing and reporting the data gathered from such testing. All duties are performed in compliance to established regulatory, compendial, and Garonit quality standards for testing finished goods. Also responsible for promoting adherence to all quality procedures and constant process improvement.
Hours:
Standard: 8:30 am to 5:00 pm, Monday through Friday
Occasionally: 2nd or 3rd shift hours and/or Saturday and Sunday may be required as necessary to support manufacturing.
Responsibilities:
Perform HPLC, GC, etc., sample preparation and testing
Review, interpret, analyze and report data according to USP/NF/BP/EP/IP/JP/CEP/cGMP, and internal guidelines.
Clean, maintain, and troubleshoot instruments.
Perform compendial monograph testing and Garonit specific tests.
Assist in developing and validating non-compendial testing as needed.
Support Laboratory Investigations, CAPA, Change Controls, Validations, Stability Programs.
Ensure lab safety and manage chemical inventory.
Train and develop other chemists.
Perform all other testing that may be required.
Perform additional laboratory duties as needed.
Audit work of other chemists.
Other duties assigned by Management.
Experience Requirements:
Experience with Empower 3
Experience working in an FDA regulated environment.
Experience with HPLC, GC, etc., sample preparation and testing.
Knowledge of USP Monograph testing, method development & validation.
Knowledge of CFR & ICH Regulatory Guidelines.
Knowledge of cGMP processes and lab safety.
5+ years of experience in a pharmaceutical chemistry lab.
Other Requirements:
Has significant technical knowledge of scientific principles, theories, and practices of analytical chemistry in an FDA inspected pharmaceutical quality control laboratory.
Indepth knowledge of all laboratory equipment, practices, and procedures.
Has excellent oral and written skills.
Has excellent interpersonal skills.
Is self-motivated.
Has a very high attention to detail.
Has a positive attitude.
Must speak, read, and write in English.
Able to stand for extended periods.
Computer Skills - Must be proficient in the following:
Word
Excel
Empower 3
Education Requirements:
Bachelor's degree in a scientific discipline (Chemistry preferred) with a minimum of 2 years' experience in HPLC.