Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Laboratory Setting
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.
Education:
- Bachelor’s degree in a physical science, preferably in Chemistry or Biology, required.
Experience:
- 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.
Equivalency:
- Equivalent combinations of education, training, and meaningful work experience may be considered.
Proficiencies:
- 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.
