Data Management Associate
Data Management Associate
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Salary Not Disclosed
1 Vacancy
Job Description
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob 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
Required Experience:
IC
Employment Type
Full-Time
