QC Scientist II

About the position

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Responsibilities

• Conducts routine chemical and physical testing of pharmaceutical raw materials, packaging components, finished products, microbiological, and stability samples by internally developed and compendial test methods.
• Completes validated test methods for pharmaceutical raw materials and finished products for strength, impurities, identity, and dissolution by HPLC, GC, dissolution, spectroscopy, and traditional quantitative analysis.
• 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 documenting the testing/analysis and acquired results.
• Records and reports results of analysis in accordance with prescribed lab procedures and systems.
• Assists in preparing regulatory documents and other communications with outside agencies, clients, and/or colleagues from other corporate sites.
• Assists in writing of SOPs if needed.
• Cleans and organizes work area, instrumentation, and testing materials.
• Cleans HPLC and dissolution systems after use.
• 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.

Requirements

• Bachelor’s or Master's degree in Chemistry or Biology is minimum education requirement.
• 2+ years of experience performing tests or analyses for pharmaceutical raw materials or finished products.
• Experience with common office software and chromatographic data acquisition systems.
• Equivalent combinations of education, training, and meaningful work experience may be considered.

Benefits

• Health and wellbeing support.
• Opportunities for career growth and development.