QC Scientist I

Job Description

Job Summary:

• The QC Scientist I performs routine analyses and documentation of any of the following:
• Residual Active Pharmaceutical and Detergent Analysis in support of pharmaceutical manufacturing operations within the QC Analytical 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.

Duties and Responsibilities:

• Conducts routine chemical testing of residual swab samples by internally developed test methods.
• Performs validated test methods for pharmaceutical residual analysis by using HPLC, Mass Spectrometry, and TOC techniques.
• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems effectively and 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 and acquired results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Prepares test solutions including diluents and mobile phases.
• Cleans and maintains work area and 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.

Required 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.

Knowledge, Skills, and Abilities:

• Working theoretical knowledge of HPLC and Mass Spectrometry is required as well as practical execution.
• Good knowledge and understanding of basic instrumental technologies and qualitative and quantitative chemical analyses.
• Awareness of quality and 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, and 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 and 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.