Quality Control Chemist II

Job Title

Quality Control Chemist II

Job Description

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 Senior Chemist will lead method development and validation projects. The Senior Chemist 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 Senior Chemist 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 Senior Chemist will oversee the general Quality Control Laboratory operation in absence of the Quality Control Manager.

EDUCATION/EXPERIENCE REQUIRED:
A BS in Chemistry or science related field is required.
Previous experience in writing and executing Method Validation protocols and reports.
Five years of experience in GMP Pharmaceutical Industry Quality Control Laboratory is a must.
Familiar with GLP in a GMP regulated industry.
Previous experience in performing and writing Laboratory Investigation.
Familiar with Monograph testing such as USP, FCC and BP.
Familiar with HPLC (UV/PDA detector) and GC (packed/capillary FID)

JOB FUNCTIONS:
• Perform out-of-specification investigations.
• Method Development/Validation
• Participate in problem-solving team as necessary.
• Perform chemical tests on finished good samples. Chemical testing may include general identification tests, etc. Testing must then be documented on appropriate forms and turned as soon as the testing is complete.
• Perform chemical assays on all manufactured products to verify proper compounding. Such chemical testing may include monograph assay, alcohol assay, specific gravity check, microbial analysis, etc. All assay work must be properly documented and all paperwork properly completed, including releasing bulk materials for production's use.
• Perform identification testing on all bulk materials (except for certain technical products) that are received. Chemical testing may include general identification tests, specific gravity, melting point, infrared spectroscopy analysis, thin-layer chromatography, etc. All chemical testing must be documented on appropriate form before any product can be released for use.
• Perform vendor qualification/certification testing according to establish procedure. All chemical analysis must then be properly documented and kept for referential use.
• Know all the analytical equipment, its function and operation. Such equipment includes Uv-vis and IR spectrophotometers, gas chromatograph, liquid chromatograph, incubator, oven, analytical scale, centrifuge, etc.
• Prepare and standardize volumetric solutions used in chemical assays. Making sure these solutions are restandardized on a regular basis to ensure quality solutions and thus accurate assays. Also responsible for preparing test solutions whenever necessary.
• Keep Retain Sample Room organized and in working order. All samples received from production lines must be recorded in a log, and after samples are tested they must be taken to the sample room and placed in the appropriate sample tray.
• Maintain sanitary working environment. All glassware must be properly cleaned after each use. All chemicals and glassware must be kept in designated place so that each person will know where to locate the equipment needed to run an assay.
• Perform accelerated and CRT stability study assays as required.
• Conduct special projects as directed by Supervisor/Management.
• Maintain Laboratory calibration system according to the current Laboratory Procedure.
• Train Laboratory and/or Chemist in new or transfer technology.

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 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

A BS in Chemistry or science related field is required.
Previous experience in writing and executing Method Validation protocols and reports.
Five years of experience in GMP Pharmaceutical Industry Quality Control Laboratory is a must.
Familiar with GLP in a GMP regulated industry.
Previous experience in performing and writing Laboratory Investigation.
Familiar with Monograph testing such as USP, FCC and BP.
Familiar with HPLC (UV/PDA detector) and GC (packed/capillary FID)