Quality Control Chemist I

Job Title

Quality Control Chemist I

Job Description

PURPOSE: To assure by chemical and physical testing that all raw materials, manufactured materials, in-process and finished products meet established specifications that impact their identity, strength, quality, purity and stability.

GENERAL DESCRIPTION:
Samples of chemical components, manufactured bulk product, and finished drug product are submitted to the QC Laboratory for testing. The Chemist utilizes standard methods of analysis and numerous analytical techniques in testing these samples. They document their results and generate reports as required by the QC Lab Director to whom they report directly.

JOB FUNCTIONS:
• Perform physicochemical tests on intermediate and finished goods. Typical testing includes active ingredient and preservative assay, viscosity, pH, density, etc. general identification tests, thin-layer chromatography, etc. Methods must be accurately followed and testing results properly, accurately and completely documented. Perform physicochemical tests on incoming chemical components (raw materials). Typical tests include assay, density, water content, LOD, ROI, identification, etc.
• Maintain organized, sanitary, and safe working environment.
• Wear adequate PPE while performing job function.
• Conduct special projects as directed by QC Lab Director


QUALIFICATIONS
• Must be proficient on classic “wet” chemistry techniques. Such as titration, gravimetric analysis, separation, decantation, filtration, precise analytical weighing, precise volumetric preparations and transfers, etc.
• Must be able to operate analytical instrumentation such as IR, UV/Vis, KF, Polarimeter, TOC, potentiometric titrator, etc.
• Have a basic knowledge of how analytical instrumentation works.
• Have a basic instrumentation troubleshooting skills.
• Must be able to interpret analytical data and be proficient in typical mathematical conversions including stoichiometry.
• Be able to derive mathematical calculations from analytical methods.
• Be able to calculate linear regressions, interpolations and extrapolations of data points.
• Must be scientific and safety minded.

PHYSICAL DEMANDS:
This position requires standing approximately 80% of the time due to laboratory bench work. Occasional assistance in product inspection (weekly) will require walking, bending, lifting (possibly up to 40 lbs. or more) as well as clerical, etc.

ENVIRONMENTAL DEMANDS:
This position requires daily working with hazardous and toxic chemicals, dust, and fumes necessitating use of personal protective equip¬ment such as safety glasses, face shields, respirators, fume hoods, etc.

PERFORMANCE STANDARDS: Within 90 days of initial employment, the chemist should be capable of running any of the standardized methods of analysis used in the lab. The output of any one chemist should be relatively close to that of any other chemist. Compliance within the guidelines of the company's Corrective Counseling Policy will be required.

BEHAVIORAL SKILLS:
Ability to make decisions and set priorities to include recognizing important elements of the job, estimating time needed to perform tasks, and drawing conclusions about problems/situations based on provided facts as needed to identify problems and recommend actions for solutions, and respond positively and effectively to emergency situations.

Ability to interact with supervisors, co-workers, and public in a courteous and professional manner, to include being flexible with work schedules and requests.

All employees will follow and uphold policies as set out and signed in HHG Employee Handbook.

Basic Qualifications

• BS in Chemistry or science related field.
• Experience working in a Chemistry Lab
• Knowledge of cGMP as per 21CFR210 and 211
• Knowledge of USP monographs and General Chapters
• Knowledge of cGMP as per 21CFR210 and 211
• Hands on experience in Classical Wet Chemistry