Quality Control Scientist

Title: QC Scientist I

Location: Cincinnati, OH

Employment Type: Temporary-to-Hire

Work Schedule: Monday–Friday, 8:00 AM – 5:00 PM

Position Summary:

The QC Scientist I performs routine analyses and documentation of any of the following: Residual Active Pharmaceutical and Detergent Analysis in support of pharmaceutical manufacturing operations within the QC Analytical Chemistry Laboratory, in a manner consistent with established standards. Supports internal development and/or manufacturing operations. Makes detailed observations & reviews, documents, and communicates test results.

Crucial Functions:

Conducts routine chemical testing of residual swab samples by internally developed test methods. Performs validated test methods for pharmaceutical residual analysis by using HPLC, Mass Spectrometry, and TOC techniques. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems effectively & efficiently. Performs daily instrument calibrations/verifications as the need arises. Clearly and accurately communicates the results of work by accurate documentation of the testing/analysis & acquired results. Records and reports results of analysis in accordance with prescribed lab procedures & systems. Prepares test solutions including diluents and mobile phases. Cleans and maintains work area & instrumentation. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains vital compliance status required by company and facility standards.

Education:

Bachelor’s degree, or greater, in physical science, preferably in Chemistry.

Experience:

1-2 years of experience performing chemical tests with chromatographic technique is preferred. Working theoretical knowledge of HPLC and Mass Spectrometry is required as well as practical execution.

Equivalency:

Equivalent combinations of education, training, & meaningful work experience may be considered.

Proficiencies:

Good knowledge & understanding of basic instrumental technologies and qualitative & quantitative chemical analyses. Awareness of quality & regulatory requirements in the pharmaceutical industry. Good problem-solving skills and logical approach to solving scientific problems. Follow all company policies, SOPs, cGMPs, work instructions, methods & analyst guidelines. Demonstrates efficiency by multitasking and scheduling time to meet required workload. Actively seek additional assignments when testing in primary area of responsibility is completed. Takes initiative and independently pursues training and/or learning opportunities to improve personal skills and share skills with other team members. Shown interpersonal and communication skills (both oral & written). Ability to read and interpret technical procedures and governmental regulations. Ability to apply mathematical operations to such tasks as determination of test reliability, analysis of variance, and correlation techniques. Ability to work in a fast-paced environment.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Use of:

• Safety glasses

• Safety shoes

• Lab coat

• Latex or similar gloves

• Safety apron

• Organic respirator occasionally (i.e. Surge 100)