Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Summary: Initiate and lead quality investigations in the Lab Operations - Analytical Operations (AO) and Development Operations (DO) including OOS and Unexpected results investigations, and Deviations. Essential Functions: Initiate and lead investigations and authors investigation reports in TrackWise. Provide technical leadership on analytical investigations. Conduct investigations with input from AO/DO supervisor Direct Scientists in the performance of lab investigations. Interact with other departments (e.g., PPT, PM, QA), clients and with Subject Matter Experts (SMEs), as required, to thoroughly investigate incidents, conclusions, and appropriate Corrective Action Preventative Actions (CAPA). Ensure investigations are ready for approval and completed within required timeframes. Provide excellence in data integrity and Good Manufacturing Practice (GMP)/procedural compliance Design and facilitate effective CAPA actions. Owns CAPA actions as needed. Challenge the department on quality issues and system improvements. Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required) REQUIRED QUALIFICATIONS Education: Bachelor of Science in Chemistry or related science Experience: Minimum 5 years analytical chemistry experience within the pharmaceutical industry Previous experience leading a team preferred Previous experience in providing client service in the contract pharmaceutical industry Previous method validation and product stability testing/reporting experience in the pharmaceutical industry. Previous investigation experience in the Good Manufacturing Practices (GMP) analytical laboratory environment. Strong interpersonal and communication skills (both oral and written) Experience with Technical Writing Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Exceptional Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH) and United States Food and Drug Administration (FDA) compliance knowledge.. Superior problem solving and troubleshooting skills. Ability to carry out investigations in a non-threatening manner with lab operations staff and effectively interacts with internal and external suppliers and clients. Excellent organizational skills with proven ability to prioritize when timeline conflicts exist. Detail oriented. Ability to work well independently and in a team environment. Experience with Microsoft Office Applications. Proficiency in the English Language. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. COVID-19 Vaccination Update for U.S. & Canada Colleagues All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment. U.S. new hires (including those in Field Sales, Field Services and Customer Support - Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles. Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
