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The World Leader In Serving Science
Data Reviewer – Small Molecule, Basic Training in Buckets 1 & 3 Required
Location
Wisconsin
Posted
7 days ago
Salary
0
Seniority
Mid Level
Job Description
Data Reviewer – Small Molecule, Basic Training in Buckets 1 & 3 Required
Thermo Fisher Scientific
• Perform review of a variety of routine and complex analytical analysis experiments conducted on pharmaceutical and biopharmaceutical compounds. • Ensure analyses are following validated or experimental analytical procedures. • Compare results to methodology, protocol and product specifications, SOPs acceptance criteria, and GMP. • Review data entered into databases and reports. • Monitor the quality of the laboratory data. • Evaluate laboratory data for compliance with analytical methods, client directives, and SOPs. • Review sample results for scientific soundness, completeness, and accurate representation of the data. • Communicate with laboratory staff to proactively maintain the quality of laboratory documentation. • Deliver review findings noting deficiencies within the analytical data or reports in a clear and concise manner. • Escalate significant deficiencies to the project leader or supervisor for assessment. • Facilitate conversations with lab staff on best documentation practices and addressing quality findings. • Advocate for quality and review process changes. • Identify and support process improvement initiatives.
Job Requirements
- Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, and experience.
- Previous experience with formal data review in GMP Lab strongly preferred.
- Basic training in buckets 1 & 3 required.
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
- Thorough knowledge of chromatography may be required.
- 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 staff on basic review techniques.
- Ability to independently review laboratory reports and analytical methods.
- 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.
- Ability to work efficiently in a remote capacity.
Benefits
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary and/or standing for typical working hours.
- Able to lift and move objects up to 25 pounds.
- Able to work in non-traditional work environments.
- Able to use and learn standard office equipment and technology with proficiency.
- May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
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