Mississauga, ON, L5B 3P7, CAN
16 hours ago
Data Management Associate
**Work Schedule** Standard (Mon-Fri) **Environmental Conditions** Office **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:** + Initiate Quality Records (Change Controls) for Analytical Release Forms (ARF), Control Procedures, CofAs, Stability Protocols, Analytical Test Methods, and Templates new and revision. + Assess and generate ARF/CofA based on Client Change request, Quality Record (QR)/Change Control requirements or new partsrequests to meet MPS (Manufacturing Production Schedule) and On Time Delivery (OTD) + Prepare new stability protocols (SPs) in accordance with client requirements. + Create and maintain specifications in SampleManager LIMS. + Support Compendial updates to evaluate impact on specifications. + Update ARFs, Control Procedures, Stability protocols and Analytical Test methods based client requests, compendial updates and QRs (DR/CAPA). + Attend Client meetings and internal readiness meeting as needed. + Addressclient comments regarding ARFs/CoAs/Stability Protocols. + 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, Ariba activities and Geenfence activities. **How will 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.
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