QC Scientist I at Thermo Fisher Scientific in Florence, South Carolina

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Laboratory Setting



Job Description




Summary:



In the role of QC Scientist I at Thermo Fisher Scientific, perform analyses in a lab setting.



Essential Functions:

• Conduct moderately sophisticated chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples using internally developed and validated test methods.


• Complete validated test methods for pharmaceutical raw materials and finished products, resolving strength, impurities, identity, and dissolution using HPLC, GC, LC/MS, dissolution, spectroscopy, and traditional quantitative analysis.


• Recognize and report any out-of-specification or unexpected results and non-routine analytical and product issues, recommending solutions.


• Maintain and troubleshoot analytical instrumentation as necessary.


• Clearly and accurately communicate results by detailing testing/analysis data and acquired results, recording and reporting findings per prescribed lab procedures and systems. Collaborate with clients as needed.


• Prepare and assist in filing regulatory documents in support of internal projects. Communicate optimally with various departments, corporate sites, agencies, and clients.


• Write SOPs and other instructional documents.


• Clean and coordinate the work area, instrumentation, and testing materials, including HPLC and dissolution systems after use.


• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines, maintaining vital compliance status per company and facility standards.

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

• 2 years of experience performing tests or analyses for pharmaceutical raw materials, finished products, or microbiological samples.


• Preferred experience with common office software and chromatographic data acquisition systems.

• Equivalent combinations of education, training, and meaningful work experience may be considered.

• Solid understanding of chemistry and analytical instrumental technologies.


• Good knowledge of qualitative and quantitative chemical or microbiological analysis.


• Familiarity with quality and regulatory requirements in the pharmaceutical industry, including GMPs and descriptive organic chemistry.


• Strong problem-solving skills and a logical approach to solving scientific problems.


• Proficiency with HPLC, GC, LC/MS, and Dissolution techniques.


• Effective interpersonal and communication skills (oral and written).


• Competence in presenting information to customers, clients, and other employees.


• Ability to read, analyze, and interpret technical procedures and governmental regulations.


• Capability to write standard operating procedures, protocols, and reports.


• Ability to address common inquiries or complaints from customers or regulatory agencies.


• Proficiency in applying mathematical operations to determine test reliability, analyze variance, and apply correlation techniques.