Job Description
RESPONSIBILITIES:
Must be able to 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.
Must record data and results as specified in documentation procedures. Documents work clearly and perform tests accurately.
Must comply with regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
Must prepare and review the analytical documents.
Associate Chemist II will be responsible to prepare and/or Review Test Procedures, SOPs, and Protocols as assigned
Responsible for maintaining independent verification testing programs with 3rd party contractor.
Perform routine laboratory analysis, such as finished product testing, dissolution testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing.
Must provide the necessary document to Support for the ANDA filing
Associate Chemist II must perform troubleshooting and investigations under the direction of a supervisor/senior QC chemist.
QUALIFICATIONS:
~ Must have BS with chemistry
~3+ years of experience as associate chemist in pharmaceutical industry.
~ QC experience in Generic pharmaceutical industry.
~ Must have good documentation practices. Knowledge in USP/ICH/FDA.
BENEFITS:
Medical Insurance
Dental Insurance
Vision Insurance
Contract to Hire
Job Tags
Contract work, For contractors,
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