Data Reviewer - Small Molecule (GMP)

Thermo Fisher Scientific • Middleton, WI

21h • Remote

About The Position

This is a fully remote role supporting our GMP Laboratory in Middleton, WI. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship and able to pass a comprehensive background check, including a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale, joining colleagues in bringing our Mission to life – enabling our customers to make the world healthier, cleaner and safer. We provide teams with resources to achieve individual career goals while advancing science through research, development, and delivery of life-changing therapies. With clinical trials in 100+ countries and ongoing development of novel frameworks, our PPD clinical research portfolio spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will improve health outcomes for people and communities. Our PPD® Laboratory Services team directly impacts patient health through the expertise of scientists, industry thought-leaders, and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. The Data Reviewer performs review of a variety of routine and complex analytical analysis experiments conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. This role ensures analyses follow validated or experimental analytical procedures, comparing results to methodology, protocol, product specifications, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP). The reviewer monitors the quality of laboratory data, including data entered into databases and reports. A thorough understanding of laboratory procedures is required to reliably conduct complex analysis review independently.

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).
• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP
• 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

Nice To Haves

• Demonstrated knowledge of PCR and sequencing strongly preferred
• Previous experience with formal data review in GMP Lab strongly preferred
• Previous experience with method validation or method validation data review strongly preferred
• Previous experience with chromatographic review and Empower strongly preferred
• Thorough knowledge of chromatography may be required.

Responsibilities

• Evaluates laboratory data for compliance with analytical methods, client directives, and SOPs.
• Reviews sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.
• Communicates with laboratory staff to proactively maintain the quality of laboratory documentation.
• Delivers 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.
• Facilitates in conversations with lab staff on best documentation practices and addressing quality findings.
• Advocates for quality and review process changes.
• Identifies and supports process improvement initiatives.
• Performs other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees