QC Chemist IV

Nature and Scope

This position is centered on testing of raw materials, in-process, and finished product samples accurately and efficiently to determine chemical identity, potency and purity of pharmaceutical products manufactured by American Regent, Inc.

Essential Duties And Responsibilities

• Successfully operate all instruments including: pH meter, Balances, Autotitrator / Karl Fischer Titrator, HPLC / GC, Atomic Absorption / ICP, UV-VIS Spectrophotometer, Osmometer, Polarograph
• Perform testing of raw materials, in-process, and finished product samples.
• Perform all wet chemistry procedures including titrations, pH measurements, etc.
• General glassware and laboratory cleaning.
• Calibrate, troubleshoot and maintain laboratory instruments.
• Maintain GMP documentation of all activities.
• Train and provide technical assistance and guidance to chemists as necessary.
• Undertake or oversee special projects, validation of new equipment, and introduction of new tests, procedures or products in the laboratory.
• Provide input and suggestions for improvement in laboratory operations and procedures.
• Write and execute instrumentation IQ/OQ and PQ protocols for analytical instrumentation, including those using new technologies.
• Facilitate analytical technology transfers and serve as liaison with outside laboratories to support QC Chemistry.
• Provide technical assistance on new and existing products to other departments.
• Review laboratory logbooks/notebooks and data packets.
• Assist Supervisor in operation of laboratory in the short term absence of the Supervisor.
• Perform any other tasks/duties as assigned by management.

Education Requirements And Qualifications

• BS Degree in Chemistry or related science with a minimum of eight (8) years pharmaceutical laboratory experience, required; or MS Degree in Chemistry or related science with five (5) years pharmaceutical laboratory experience.
• Strong background in analytical instrumentation and wet chemistry techniques.
• Proficient with analytical instruments such as HPLC, GC, AA, UV-VIS, ICP, etc.
• Knowledge of Empower, MS Word, Excel and Outlook.
• Detail oriented, advanced analytical knowledge and thinking and strong time management skills.

Physical Environment And Requirements

• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.