Quality Control Scientist

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 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/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/Abilites:

• 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.