Data Reviewer - Cell Bioassay (GMP Lab)

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. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Our PPD® Laboratory Services team has a direct impact on improving 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! Discover Impactful Work: The Data Reviewer performs review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices. 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 of the laboratory data. Possesses a thorough understanding of laboratory procedures and can reliably conduct complex analysis review independently. A Day in the Life: 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.

Responsibilities

• Performs review of a variety of routine and complex analytical analysis experiments that are conducted on pharmaceutical and biopharmaceutical compounds with various formulations and/or biological matrices.
• 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 of the laboratory data.
• 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.

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). In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
• 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 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 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
• 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.

Benefits

• Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

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