Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Data Reviewer- Remote, Biopharma

At PPD, part of 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, our work spans laboratory, digital and decentralized clinical trial services.

• Ensures the quality of laboratory data and reports.

• Reviews chromatographic data, related notebooks and sample results for scientific soundness, completeness, accurate representation of the data, and final reported results.

• Evaluates data to ensure compliance with analytical methods, client criteria, Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).

• Delivers review findings noting deficiencies within the analytical data or reports in a clear and concise manner

• Communicates with laboratory staff to proactively address the quality of laboratory documentation.

• Prepares QC statements noting deficiencies with the analytical data set or notebooks.

• Reports deficiencies to the project leader for correction.

• 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.

• BSc in Science or related field required

• 2+ years of QA/QC experience required (gaining thorough knowledge of chromatography and including experience in reviewing analytical data/results)

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

• Strong verbal and written communication skills

• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards

• Ability to independently review laboratory reports and analytical methods

• Strong attention to detail

• Ability to provide clear and concise feedback and/or documentation of results

• 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.