**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 Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.