Quality Control Chemist II

Job Title

Quality Control Chemist II

Job Description

REPORTS TO: QC Lab Manager

PURPOSE:

To solve analytical problems through good scientific methods and help design, validate and transfer new or improved analytical methods. To complete assigned method research and development projects as assigned. To be a back-up of the QC Lab Manager as needed. 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:

The QC Chemist II will lead method development and validation projects. The QC Chemist II will perform peer review, out-of-specification investigations, help in the development, validation, and technology transfer of new or improved analytical methods. Coach and mentor junior analysts. Perform calibration of HPLC and GC as needed. The QC Chemist II utilizes standard methods of analysis and numerous analytical tech-niques in the testing of bulk chemicals, manufactured bulk product, and finished drug products that are submitted to the QC Laboratory. The QC Chemist II will oversee the general Quality Control Laboratory operation in absence of the Quality Control Lab Manager.

EDUCATION/EXPERIENCE REQUIRED:

JOB FUNCTIONS:

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. Specific vision abilities required by this job include close vision and color recognition.

ENVIRONMENTAL DEMANDS:

This position requires daily working with hazardous and toxic chemi¬cals, 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 Senior Chemist should be capable of running any of the standardized methods of analysis used in the lab.

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, schedule work for self and others, work without direct supervision, and respond to emergency situations.

Ability to interact with supervisors, co-workers, and public to include being flexible with work schedules and requests; remaining calm and courteous and exercising self control when sharing information and when interacting with angry individuals; accepting criticism without over-reacting or getting angry; and being open to and sharing ideas as needed to conduct training, handle complaints and encroachment situations, explain policies and procedures, and maintain good relations within the company.

Basic Qualifications