Role at a glance
- Salary
- Not Disclosed
- Location
- Remote - Ireland
- Work arrangement
- Remote
- Employment
- Full-time
- Experience
- 2+ years of QA/QC analytical experience is essential (gaining thorough knowledge of cell based assays and including experience in reviewing analytical data/results)
- Education
- BSc in Science or related field required
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Role Summary
The Data Reviewer supports Cell Laboratory teams by reviewing laboratory and chromatographic data and reports for quality, integrity, and compliance with applicable procedures and criteria. The role communicates review findings to laboratory staff and project leaders and supports improvements to documentation and review processes.
What You'll Do
- Review chromatographic data, related notebooks, and sample results for scientific soundness, completeness, and accurate reporting.
- Evaluate data for compliance with analytical methods, client criteria, GLP, and GMP.
- Document deficiencies in analytical data, reports, and notebooks, and report them to project leaders for correction.
- Communicate with laboratory staff about documentation quality and best practices.
- Support process improvement initiatives and advocate for quality and review process changes.
Generated from the employer's posting. Verify important details before applying.
View full postingQualifications
Required: BSc in Science or a related field; 2+ years of QA/QC analytical experience, including knowledge of cell-based assays and experience reviewing analytical data/results; thorough knowledge of SOPs and Federal Regulations including GLP and GMP; strong verbal and written communication skills; technical knowledge of laboratory procedures, methodology, and standards; ability to independently review laboratory reports and analytical methods; attention to detail; and ability to provide clear, concise feedback or documentation of results.
Required
- BSc in Science or related field
- 2+ years of QA/QC analytical experience, including knowledge of cell-based assays and experience reviewing analytical data/results
- Thorough knowledge of SOPs and Federal Regulations, including GLP and GMP
- Strong verbal and written communication skills
- Technical knowledge 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 or documentation of results
Original job description
Content provided by the employer
Original job description
Content provided by the employer
Work Schedule
Standard (Mon-Fri)Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Data Reviewer- Remote, Cell Lab
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 Cell 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, 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.
Education and Experience
- BSc in Science or related field required
- 2+ years of QA/QC analytical experience is essential (gaining thorough knowledge of cell based assays 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.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
About the company
Thermo Fisher Scientific
Large Enterprise
Thermo Fisher Scientific is a global leader in serving science, providing a wide range of analytical instruments, reagents, and software solutions for healthcare, pharmaceuticals, and life sciences research. With a commitment to innovation and quality, the company enables customers to make significant advancements in scientific discovery and healthcare diagnostics. Thermo Fisher operates in more than 50 countries and employs over 80,000 people, fostering a collaborative environment aimed at enhancing global health and safety. Through its broad portfolio of brands and technologies, the company plays a vital role in accelerating life-changing research and improving patient outcomes worldwide.