Quality Control Scientist

3 weeks ago


Cincinnati, United States Infotree Global Solutions Full time

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:

  • routine chemical testing of finished products, and stability samples by internally developed and compendial test methods.
  • validated test methods for pharmaceutical finished products for strength, impurities, identity, and characteristics by using HPLC and wet chemistry techniques.
  • and reports out-of-specification or unexpected results and non-routine analytical and product problems efficiently.
  • daily instrument calibrations/verifications as required.
  • and accurately communicates the results of work by accurate documentation of the testing/analysis & acquired results.
  • and reports results of analysis in accordance with prescribed lab procedures & systems.
  • test solutions including diluents and mobile phases.
  • and maintains work area & instrumentation
  • all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines.
  • vital compliance status required by company and facility standards.

Education/Experience:

  • degree, or greater, in physical science, preferably in Chemistry.
  • years of experience performing chemical tests with chromatographic technique is preferred.
  • theoretical knowledge of HPLC is required as well as practical execution.
  • combinations of education, training, & meaningful work experience may be considered.

Knowledge/Skills/Abilites:

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


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