Data Management Associate
7 days ago
**Data Management Associate**
**How will you make an impact?**
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe and you’ll be valued and recognized for your performance. With dedicated managers and inspiring coworkers to support you, you’ll find the resources and opportunities to make significant contributions to the world while building a vibrant career
**What will you do?**
Provides support for Lab Operations (LO) activities such as Analytical Release Forms (ARFs), Specification, Control procedures, Stability Protocol and Analytical Methods, Data Package Preparations, Compendial updates, and Analytical gap assessments.
**Responsibilities**:
- Initiates QR/Change Controls for ARFs, Control Procedures and Stability Protocols (New, revision and discontinuation).
- Generates ARF based on QR / Change Control requirements or new part requirements
- Generates and revises Specifications for LO per SharePoint requests
- Reviews, updates and maintains index database
- Supports Gvault activities
- Performs Compendial updates and requests for ILQ (Inter Lab Qualification) activity
- Writes Elemental Impurities and Residual Solvents Risk assessments reports
- Write Analytical gap assessment reports based on client requests, vendor change notifications and compendia updates
- Reviews, updates, and maintains indexes
- Reviews change controls that impact product/equipment/ packaging for the Elemental Impurities
- Effectively and actively follows up with clients and other supporting teams to ensure that all Quality Records are completed in a timely manner to support analytical testing and production schedules
- Support activities associated with QDIS and LIMS Sample Manager (Build/Test/Review)
- May be essential to perform alternating or rotating shift work (as required).
**Data Package Management**
- Prepares and creates data packages per Lab Operations requests by collecting data and information
- Works with lab and reviewer groups to address client comments regarding data packages
**How will you get there?**
**Requirements**:
**Education**:
- Preferred Bachelor of Science (B.Sc.) or a College Diploma in chemistry, biology, pharmacy, or other related fields
**Experience**:
- 1 year of previous experience in a science-related environment is preferred.
**Knowledge, Skills and Abilities**:
- Computer proficiency with Microsoft Office programs (e.g., Outlook, Excel, Word).
- Excellent interpersonal skills (verbal and written).
- Ability to multitask.
- Detail Oriented and reliable.
- Proficiency in the English language.
- Works well independently and in a team environment.
**About Thermo Fisher Scientific**
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or augmenting efficiency in their laboratories, we are here to support them. Our distributed team of more than 100,000 colleagues 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 and Patheon. We share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at ThermoFisher Scientific, where diverse experiences, backgrounds and perspectives are valued
- 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._
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