QC Scientist I

Work Schedule

Environmental Conditions

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.

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.