Data Management Associate
Top Benefits
About the role
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
About Thermo Fisher Scientific
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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.
For more information, please visit www.thermofisher.com.
Data Management Associate
Top Benefits
About the role
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
About Thermo Fisher Scientific
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $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.
For more information, please visit www.thermofisher.com.