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. The QC Chemist IV will perform analytical testing according to current guidance and established procedures for analysis of stability samples in the Quality Control Laboratories.

Essential Duties and Responsibilities

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

• 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.

• Perform calibration, basic troubleshooting and maintenance on 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

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• 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.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

• 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.

Expected Salary Range:

$117,900 - $125,000

The salary range, displayed is the  minimum and maximum annual salary range of compensation for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role.  Actual compensation for the role will be based on a number of different factors including but not limited to the candidate’s qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.