Senior Chemist-Metrology
Overview: Performs routine chemical analysis work and reviewing involving pharmaceutical raw materials, process intermediates, and finished products in accordance with cGMPs, and SOPs under minimal supervision.Responsibilities:
Assist and coordinate the activities of the QC laboratory.
Direct and conduct laboratory procedures for routine and non-routine QC projects.
Conduct and assist laboratory staff in performing tests and controlling the flow of work.
Calcualtes/ Reviews/ Interpret physical and chemical analyses.
Interpret test results, prepare test reports, review laboratory notebooks and forms.
Notify Supervisor of Out-of-Specification(OOS) / Out-of-Trend(OOT) samples.
Assist with preparing Out-of-Specification (OOS) investigations to establish integrity of data.
Assist with preparing, writing, maintaining, and editing Specifications, Standard test methods, and Standard Operating Procedures.
Operate, maintain, troubleshoot, and calibrate equipment in assigned area.
Determine and evaluate instrument needs for the QC laboratory.
Proficient in troubleshooting and computer usage.
Train and supervise others.
Assist with Method Transfers for the Quality Control Laboratory.
Adheres to cGMP and Andrx SOPs.
Perform related work as assigned.Job Requirements
Qualifications:
Four-year degree in a Science discipline with at least 7 years of relevant work experience, or equivalent.
Master’s Degree in a Science discipline with at least 5 years of relevant work experience, or equivalent.PhD with a minimum of 1 year of relevant work experience, or equivalent.
Knowledge of Microsoft Suite,
Knowledge of the principles and techniques of quantitative and qualitative chemical laboratory tests.
Skill in the operation of laboratory equipment (HPLC, GC, KF, pH meters, analytical balances, etc).
Ability to conduct physical and chemical analyses and tests, to interpret test results, and to prepare concise reports.
Excellent interpersonal, written, and verbal skills. Ability to train and mentor lower level analysts.
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