Work Schedule Standard Office Hours (40/wk) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards Job Description How will you make an impact: Provide support for Lab Operations (LO) activities such as generating, reviewing and revising specifications for Finished Products, intermediates and Raw Materials (RM) and stability protocols. Support with Certificates of Analysis (CofAs) issuance for In-Process, Raw Material, Bulk and Finished Product. Support with Vendor change assessments, material gap analysis, compendial update assessments, Residual Solvent and Elemental impurity assessments. What will you do? Training Record Management Support and maintain training records for Lab Operations Manage SuccessFactors Learning Management System (SFLMS) activities for Lab Operations Act as the Department lead and troubleshoots for SFLMS issues and provides support to end users Ensure Lab Operations aligns with SFLMS requirements Provide ongoing training and expertise to department users Develop Work Instruction (WI) related to Standard Operating Procedures (SOPs) or SFLMS as needed Train the designated Lab Administrator to assist on SuccessFactors and Documentum admin work. ARF/Specification/CofAs/Compendial Updates, Elemental and Residual Solvent risk assessment Management Generate ARF/CoA based on Quality Record (QR)/Change Control requirements or new parts requests to meet MPS (Manufacturing Production Schedule) and On Time Delivery (OTD) of QRs Generate and revise Specifications/eCoAs per SharePoint requests Address client comments regarding ARFs/CoAs Review, update and maintain ARF index database Support Annual product review (APR) (as needed) Support indexing, filing and archival of obsoleted Artworks Support Gvault activities Support Compendial updates Support SampleManager activities Data Package Management Prepare and create data package per Lab Operations requests by collecting data and information Work with lab and reviewer groups to addresses data package related client comments Maintain a safe working environment and report potential hazards. Perform alternating or rotating shift work (as required) How will you get here: Education: Bachelor of Science in chemistry, biology, pharmacy, or other related field Experience: Previous experience in a science related environment. Minimum 2 years of working experience as Lab Administrator or equivalent. Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered. Knowledge, Skills and Abilities: Computer proficiency with Microsoft Office programs (e.g., Outlook, Excel, Word). Excellent interpersonal skills (verbal and written). Ability to multi-task. Detail Oriented and reliable. Works well independently and in a team environment. Proficiency with the English language. Benefits We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, company savings plan, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation 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.
