QC Analytical Data Reviewer, Biopharma - Remote

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.

Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Location/Division Specific Information

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. 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 role of Data Reviewer is to support our Laboratory teams in ensuring the integrity and quality of laboratory and chromatographic data and reports. 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. This is the perfect job for someone who has strong review experience and is looking to move away from hands on lab duties.

A day in the Life

• Ensures the quality of laboratory data and reports.

• Reviews chromatographic data, related notebooks and sample results for scientific soundness, completeness, accuraterepresentation 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.

Education and Experience

• BSc in Science or related field required

• 2+ years of QA/QC analytical experience is essential(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

Work Environment

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. Below is listed the working environment/requirements for this role:

• 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.