QC Analytical Data Reviewer, Biopharma

Job Summary: QC Analytical Data Reviewer, Biopharma

As a QC Analytical Data Reviewer, Biopharma at PPD, part of Thermo Fisher Scientific, you will play a crucial role in ensuring the integrity and quality of laboratory and chromatographic data and reports. This remote position is ideal for an experienced professional looking to transition from hands-on lab work to a dedicated data review function. Your determination to deliver quality and accuracy will directly contribute to improving health outcomes globally.

Discover Impactful Work

This role supports our PPD® Laboratory Services team by ensuring all analyses comply with validated or experimental analytical procedures, methodology, protocols, product specifications, Standard Operating Procedures (SOPs), acceptance criteria, and Good Manufacturing Practices (GMP). You will be responsible for reviewing data entered into databases and reports, and continuously monitoring the quality of laboratory data to uphold the highest standards.

A Day in the Life

• Ensuring the quality and integrity of laboratory data and reports.
• Reviewing chromatographic data, associated notebooks, and sample results for scientific soundness, completeness, accuracy, and proper representation of data, including final reported results.
• Evaluating data to ensure strict compliance with analytical methods, client criteria, Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP).
• Documenting review findings, noting any deficiencies within the analytical data or reports in a clear and concise manner.
• Communicating proactively with laboratory staff to address and improve the quality of laboratory documentation.
• Preparing QC statements detailing deficiencies and reporting them to the project leader for timely correction.
• Facilitating discussions with lab staff on best documentation practices and strategies for addressing quality findings.
• Actively advocating for quality and review process enhancements and supporting process improvement initiatives.

Education and Experience

To succeed in this role, you should possess:

• A Bachelor of Science (BSc) degree in a scientific or related field.
• At least 2 years of essential QA/QC analytical experience, demonstrating thorough knowledge of chromatography and expertise in reviewing analytical data/results.
• Comprehensive knowledge of SOPs and Federal Regulations, including GLP and GMP.
• Strong verbal and written communication skills for effective interaction and documentation.
• Robust technical knowledge, encompassing an understanding of laboratory procedures, methodology, and industry standards.
• The ability to independently review complex laboratory reports and analytical methods.
• Exceptional attention to detail, critical for maintaining high data quality.
• The capability to provide clear, concise feedback and thorough documentation of results.

Work Environment

Thermo Fisher Scientific prioritizes the health and wellbeing of its employees. While this is a remote role, the environment may involve:

• Communicating, receiving, and understanding information with diverse groups.
• Working upright and stationary and/or standing for typical working hours.
• Lifting and moving objects up to 25 pounds occasionally.
• Operating in non-traditional work environments.
• Proficiently using and learning standard office equipment and technology.
• Potential exposure to hazardous elements, including infectious agents, typical in healthcare or laboratory environments (though remote, this refers to general company operations).
• Performing successfully under pressure, prioritizing, and managing multiple projects.

Key Skills/Competency

• Analytical Data Review
• Quality Control (QC)
• Good Manufacturing Practices (GMP)
• Good Laboratory Practices (GLP)
• Chromatography
• Standard Operating Procedures (SOPs)
• Data Integrity
• Biopharmaceutical Analysis
• Documentation
• Regulatory Compliance