Data Reviewer - Cell Lab

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Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

Join us as a Data Reviewer - Cell Lab!

At 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 through our PPD clinical research portfolio, 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.

Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

This role is based at our GMP Laboratories in Athlone supporting of Cell and Molecular lab.

As a Data Reviewer , your role is to support our Laboratory teams in ensuring the integrity and quality of laboratory 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, Cell & Molecular 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 laboratory 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 lab analytical experience is essential (gaining thorough knowledge of cell techniques such as bioassay experience, mammalian cell culture, flow cytometry, PCR 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
  
  

In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Working Conditions And Environment

• Work is performed in a laboratory and/or a clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations, occasional domestic travel.
• Exposure to biological fluids with potential exposure to infectious organisms.
• Rare exposure to skin and lung irritants, radiation, toxic materials and hazardous waste.
• Personal protective equipment required such as protective eyewear, garments and gloves.
• Exposure to fluctuating and/or extreme temperatures on rare occasions.
  
  

Physical Requirements

• Ability to work in an upright and /or stationary position for 6-8 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists to operate lab equipment.
• Occasional mobility needed.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• Frequently interacts with others to obtain or relate information to diverse groups.
• Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
• Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
• Regular and consistent attendance.
  
  

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience – and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthrough.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you have questions about this posting, please contact [email protected]