QC Analytical Data Reviewer, Pharma - Remote

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 decentralised 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 QC Data Reviewer - Pharma will support our analytical team in our GMP Pharma Laboratory in Athlone.

As a QC Data Reviewer – Pharma you will monitor the quality of laboratory data and reports, chromatographic data and related notebooks as specified by Standard Operating Procedures.

A day in the Life 

• Evaluates laboratory data for compliance with analytical methods and SOPs.
• Reviews sample results for completeness and accurate representation of the data and report findings.
• 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.
• Trains new QC Reviewers and laboratory staff.
• Conducts SOP review and writing. Conducts consultations for quality records.
• Performs other duties as assigned.

Education and Experience 

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification 
• Min. 2 years experience - laboratory analytical experience utilising chemistry analytical techniques with proven experience reviewing analytical data.
• Experience in chromatography, Empower, HPLC, dissolution

Knowledge, Skills, Abilities 

• Thorough knowledge of SOPs and Federal Regulations to include GLP and GMP 
• Thorough knowledge of chromatography and divisional SOPs  
• Strong technical knowledge including an understanding of laboratory procedures, methodology and standards  
• Strong verbal and written communication skills  
• Strong attention to detail  
• Ability to train staff  
• Ability to independently review laboratory reports and analytical methods  
• 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 

Work Environment 

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to build 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 prioritising and handling multiple projects or activities.