Clinical and Health - QC Scientist

Position: Clinical and Health - QC Scientist I
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, or improving patient diagnostics and therapies, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

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Summary of position:
The QC Scientist I performs routine analyses and documentation of any of the following:
Raw Materials, In-Process, Finished Product, Calibrations, Stability, Technical Service 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 and reviews, documents, and communicates test results.

Essential Functions:

• Conducts routine chemical and physical testing of raw materials, packaging components, finished products, and stability samples by internally developed and compendial test methods.

• Executes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and characteristics by utilizing HPLC, GC, LC/MS, dissolution, spectroscopy, and/or traditional wet chemical testing.

• Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems.

• Performs daily instrument calibrations / verifications as required.

• 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 dissolution medias and mobile phases.

• Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.

• 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 the vital compliance status required by company and facility standards.

Education:

Bachelor's degree in physical science, preferably in Chemistry or Biology.

Experience:

Typically requires no previous related experience. Experience performing chemical tests with chromatographic, spectroscopic, or other analytical technique preferred.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.
Proficiencies:

• 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.

• Compliance:
Actively contribute to the overall goals of the company. Follow all company policies, SOPs, cGMPs, work instructions, methods and analyst's guidelines.

• Efficiency:
Multitasks and schedules time to meet required workload. Actively seek additional assignments when testing in primary area of responsibility is completed. As required by the group's workload, is available for off-shift or weekend assignments, or for emergency/problem situations.

• Initiative:
Independently pursue training and/or learning opportunities to improve personal skills and share skills with other team members.

• Demonstrable 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

Physic…