Job Title: Scientist
Location: Cincinnati, OH
Duration: 12+ months
Monday to Friday, flexible 6-9am start time. Must work 8 hours per day.
Position Summary:
- The Quality Control Scientist I performs routine analyses and documentation of any of the following: In-Process and Finished Product samples for pharmaceutical batch Release, 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.
Job Functions:
- Conducts routine chemical testing of finished products, and stability samples by internally developed and compendial chromatographic test methods.
- Performs validated test methods for pharmaceutical finished products for strength, impurities, identity, and characteristics by using HPLC and wet chemistry techniques.
- Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems efficiently.
- Performs daily instrument calibrations/verifications as required.
- Clearly and accurately communicates the results of work by accurate documentation of the testing/analysis & acquired results.
- Records and reports result 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/Experience:
- Bachelor’s degree, or greater, in physical science, preferably in Chemistry.
- 1-2 years of experience performing chemical tests with chromatographic technique is preferred.
- Working theoretical knowledge of HPLC is required as well as practical execution.
- Equivalent combinations of education, training, & meaningful work experience may be considered.
Knowledge/Skills/Abilities:
- 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 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.