Data Reviewer - Lab Support

Work Schedule

Environmental Conditions

Job Description

Data Reviewer – Lab Support

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.

Data Reviewer – Lab Support

This role will be based in our Analytical GMP Labs in Athlone and will work within our Metrology team. The metrology team supports all assets onsite. And the Data reviewer will review metrology work to release equipment for use in the labs.

Responsibilities:

• Performs review of a variety of basic and complex calibration, maintenance and qualification activities that are conducted on various laboratory instrumentation and equipment.
• Ensures work follows standard procedures and compares results to industry standards, Standard Operating Procedures (SOPs) acceptance criteria, and Good Manufacturing Practices (GMP).
• Monitors the quality of the lab support data.
• Possesses a thorough understanding of lab support procedures and can reliably conduct complex review independently.
• Evaluates lab support data for compliance with SOPs.
• Reviews results for scientific soundness, completeness, and accurate
  representation of the data.
• Delivers review findings noting deficiencies in a clear and concise
  manner.
• Facilitates in conversations with lab support staff proactively to maintain
  the quality of documentation, communicate best documentation
  practices and address quality findings.
• Escalates significant deficiencies to the team lead or supervisor for
  assessment.
• Trains and/or mentors new data reviewers and lab support staff in basic and
  complex data review processes.
• Advocates for quality and drives review process changes.
• Assists the departmental manager or supervisor in the evaluation of the
  lab support data review process.
• Identifies and drives general process improvement initiatives.
• Performs other duties as assigned.

Education and Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years’) or equivalent combination of education, training, & experience.
• Experience should include working with analytical equipment within lab setting, reviewing analytical data, experience with equipment (i.e. calibration, troubleshooting, repair or review of same)

Knowledge, Skills and Abilities:

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP.
• Thorough knowledge of chromatography may be required.
• To demonstrate behaviours which align to the 4i Values of Thermo Fisher
• Strong technical knowledge including an understanding of lab support procedures and industry standards.
• Strong verbal and written communication skills.
• Strong attention to detail.
• Ability to balance time and remain focused on work to meet goals.
• Ability to train and mentor junior data review and lab staff.
• Ability to lead a small to moderate project team or process improvement.
• Ability to independently review lab support records with minimal oversight.
• Ability to deal with multiple and changing priorities.
• Ability to provide clear and concise feedback and/or documentation of results.
• Ability to work in a collaborative team environment.

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

We welcome and encourage applicants from outside of Ireland. We can provide support with immigration and visa needs for successful applicants and dependents, tax consultations and other basic destination services. All other relocation costs are at the expense of the applicant.