Top Benefits
About the role
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 parts requests 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.
-
Address client 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.
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.
Top Benefits
About the role
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 parts requests 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.
-
Address client 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.
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.