Thermo Fisher Scientific
Sr Data Reviewer – Small Molecule
USARemotePosted Today
Full TimeSeniorRemoteUS
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Job Description
Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety StandardsJob DescriptionThis is a fully remote role supporting our GMP Laboratory in M
Key Highlights
- Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness.
- Reviews development analyses of non-routine projects. Performs analytical data review of method qualification, verification, and validations interpreting the data for compliance and technical soundness.
- Performs reviews routine and non-routine protocol and methods.
- Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.
- Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner.
Qualifications
Required Qualifications
- Previous experience with formal data review in GMP Lab strongly preferred
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Thorough knowledge of chromatography may be required
- To demonstrate behaviors which align to the 4i Values of Thermo Fisher
- Strong technical knowledge of method validation and probable cause evaluation
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Strong verbal and written communication skills
- Strong attention to detail
- Ability to balance time and remain focused on work to meet goals
- Ability to train and mentor junior data review and lab staff
- Ability to independently review laboratory reports and analytical methods with minimal oversight
- Ability to deal with multiple and changing priorities
- Ability to provide clear and concise feedback and/or documentation of results
- Ability to work in a collaborative team environment
About the Company
Thermo Fisher Scientific
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Job Details
Employment Type
Full Time
Experience Level
Senior
Location
USA
Work Mode
Remote
Posted
Today
Country
US