[Hiring] QC Analytical Data Reviewer @Thermo Fisher Scientific

Role Description

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.
• Compares 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, 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 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.

Qualifications

• BSc in Science or related field required.
• 2+ years of QA/QC analytical experience is essential.
• 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.

Requirements

• 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

• Support and encouragement for a healthy and balanced environment.