Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Duration: April 2025 - December 2025 (co-op students only) Summary: Provide administrative support to the Compliance department. Support the preparation for regulatory inspections and client audits. Maintain documents and prepare packages to support regulatory and client requests. Assist with regulatory and licensing activities to ensure site compliance with regulatory and corporate requirements. Support the retention sample destruction process to ensure timely destruction of samples. Essential Functions: Provide administrative support for ongoing Compliance projects. Support Compliance auditors regarding inspection readiness, client communication and scheduling of client/ regulatory audits. Support regulatory, corporate, client, and internal audits. Scribe for regulatory/corporate and any for cause or critical client audits. Create/issue memos for regulatory inspection history Send inspection notifications to site Generate USDA, Allergen, Viral Letters and BSE / TSE Statements Maintain the DPL database and assist with FDA Drug Product Listing. Assist clients in procuring and legalizing GMP Certificates Verify information entered into SAP for new material number creation. Provide eDMS support to the Compliance team by initiating and progressing document revisions. Oversee the retention sample destruction process Maintain a safe working environment and report potential hazards. REQUIRED QUALIFICATIONS Education: High school diploma/General Educational Development (GED) Certificate is required. Working towards College Diploma or University Degree in relevant technical field. Enrolled in co-op program Experience: Requires no previous related experience. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Familiar with GMP, HPFBI, FDA and SOP requirements. Excellent interpersonal, organizational, oral and written communication skills. Familiarity with TrackWise an asset. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with 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.
