QC Data Reviewer

Work Schedule

Environmental Conditions

Job Description

Job Description

Business Job Title:                     Lead QC Technician 

Job Profile Title:  (Internal title)  QC Data Reviewer 

Direct Report To:                        QC Section Head

Group/ Division:                          PSG 

Career Band:                              04 

Career Track:                             Associate 

Position Location:                      Swindon 

When you’re part of Thermo Fisher Scientific, you’ll do meaningful work, and join a team that values performance, quality and innovation. As an ambitious member of a successful, growing global organization you will be encouraged to perform at your best! With have revenues of $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world!

Position Summary:  

 This role is a site based role responsible for the cGMP review of QC Chemistry analytical documentation, logbooks, and analytical instrument electronic records. 

Responsibilities:

· To ensure cGMP is applied in all areas of the business and perform GMP data review quality control analytical testing of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or stability studies. 

·To mentor and provide training for QC Analysts to ensure that there is understanding of the need for any corrections and build knowledge of how to improve data presentation in the future. 

·To author and review technical documentation including but not limited to standard operating procedures, investigations, reports, and QC logbooks for accuracy and completeness. 

·To perform tracking and trending of Laboratory Investigations, Laboratory events, and right first time (RFT) data for QC Chemistry with regards to analytical RFT and documentation RFT.

·To maintain own training records and support and train other team members as required. 

·To participate in continuous improvement activities and look for further opportunities to build progress for the team/department. 

·Effectively communicate on site and internationally, and to participate with them in problem solving activities. 

·To carry out any other tasks which may be required from time to time. 

EH&S

·Understand emergency procedures and follow safe systems of work, strive to maintain good housekeeping and 5S. 

·Ensure compliance with environment, health and safety rules, signage and instructions at all times. 

·Ensure timely reporting and investigation of all accidents, near misses and breaches of rules. 

Minimum Requirements/Qualifications: 

·Degree in Chemistry or strongly related scientific subject area  

·Experience of instrumental and traditional analytical techniques, ideally 2 years

·Ability to work to critical timelines with excellent organisation and attention to detail

·Proficient communication skills at all internal and external levels.

Our globally distributed team of more than 100,000 colleagues delivers an unrivalled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer, and we do 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.