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

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