Quality Control Scientist
3 weeks ago
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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