QC Scientist I/Research Associate

Job Title:       QC Scientist I

Location:       Cincinnati, OH, 45237    

Work type:    Onsite  

Position Summary:

The QC Scientist I performs routine analyses and documentation of any of the following: Raw Materials, In-Process, Finished Products, Calibrations, Stability samples, or projects within the QC 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 & physical testing of raw materials, finished products, and stability samples by internally developed and compendial test methods.
• Performs validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and characteristics by using HPLC, GC, dissolution, spectroscopy, and/or traditional wet chemical testing.
• 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 by 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/Experience:

• Bachelor’s degree, or greater, in physical science, preferably in Chemistry or Biology.
• Experience performing chemical tests with chromatographic, spectroscopic, or other analytical techniques preferred.
• 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 a 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 the required workload.
• Actively seek additional assignments when testing in the 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; 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; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods; ability to sit, reach with hands and arms, talk, and hear for prolonged periods. Use of:

• Safety glasses
• Safety shoes
• Lab coat
• Latex or similar gloves
• Safety apron
• Organic respirator occasionally (i.e. Surge 100)