QC Scientist I

The Quality Difference at Thermo Fisher Scientific: What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind. Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world. When you join our team of quality professionals, you’ll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.

Back to search results

Previous job

Next job

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.

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.