Clinical and Health - QC Scientist

Position: Clinical and Health - QC Scientist I
SUMMARY

The QC Scientist provides routine analyses in a chemistry or microbiology environment by following standard practices. Performs analytical methods as assigned for testing on raw materials, samples, stability, environmental, production intermediates, and/or human cells. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Conducts routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendia test methods. Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis, utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.

Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems. Performs daily instrument calibrations / verifications as required. Clearly and accurately communicates the results of work by creating documentation of the testing/analysis and obtained results. Records and reports results of analysis in accordance with prescribed lab procedures and systems. Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.

Contributes to writing of SOPs if needed. Cleans and organizes work area, instrumentation, and testing materials. Cleans HPLC and dissolution systems after use. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards.

QUALIFICATIONS

Typically requires no previous related experience. Experience performing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.

EDUCATION AND EXPERIENCE:

Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry or related field is preferred. Minimum education requirements include a high school diploma or equivalent.

Experience with common office software and chromatographic data acquisition systems.
1-2 years of experience working in a laboratory, (GLP or GMP/cGMP environment preferred)
Equivalent combinations of education, training, and relevant work experience may be considered.

LANGUAGE

SKILLS:

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to effectively present information and respond to questions.

REASONING ABILITY:

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

Able to obtain DEA registration.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function.

While performing the essential duties of this job, the employee is occasionally required to sit, climb or balance, use hands to finger, handle, or feel, stoop, kneel, crawl, or crouch, and talk/hear/listen (communicate with others). The employee may occasionally be required to push/pull/lift/carry up to 50 pounds. Close vision is required. Ability to wear a negative pressure respirator is required.

WORK ENVIRONMENT

The employee may be exposed to fumes or airborne particles, toxic or caustic chemicals, risk of electrical shock, and risk of radiation. The noise level is moderate.

PERSONAL PROTECTIVE EQUIPMENT

Lab coat, safety shoes, safety glasses with side shields, protective gloves will all be provided. Respirator will be required at times.
Additional Sills:

Skills:

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