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The World Leader In Serving Science
Senior Data Reviewer – Biopharm
Location
Wisconsin
Posted
7 days ago
Salary
0
Seniority
Senior
Job Description
Senior Data Reviewer – Biopharm
Thermo Fisher Scientific
• Performs review of a variety of complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds in various formulations and/or biological matrices. • Possess a thorough understanding of laboratory procedures and can reliably conduct routine, non-routine (method establishment), and complex analytical data review ensuring scientific soundness and adhering to method validation. • Ensures analyses are following validated or experimental analytical procedures, and compare results to methodology, protocol and product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). • Reviews data entered into databases and reports and monitors the quality and scientific soundness of the laboratory data. • Performs complex analytical data review, evaluating laboratory data for compliance with analytical methods, SOPs, client directives and scientific soundness. • Trains new Data Reviewers and laboratory staff in basic and complex analytical data review. • Mentors junior data review staff in review process. • Identifies and drives process improvement initiatives.
Job Requirements
- Bachelor’s degree or equivalent
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
- Previous experience with formal data review in GMP Lab strongly preferred
- Previous experience with Biopharmaceutical techniques preferred
- Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
- Thorough knowledge of chromatography may be required
- Strong technical knowledge of method validation and probable cause evaluation
- Strong technical knowledge including an understanding of laboratory procedures, methodology and standards
- Strong attention to detail
- Ability to train and mentor junior data review and lab staff
Benefits
- Health and wellbeing support
- Employee training programs
- Career development opportunities
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