QA Officer

Work Schedule

Rotational shift days

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
Join Thermo Fisher Scientific as a Lead QA Technician and contribute to ensuring product quality and regulatory compliance. As a member of our Quality team, you'll help enable our mission of making the world healthier, cleaner and safer through quality oversight of pharmaceutical manufacturing operations. Your expertise will help maintain high standards of quality while supporting production of life-changing medicines.

This QA Officer role will be based at the Thermo Fisher Scientific Cramlington facility on an early and late (weekly) rotation 06:00 – 14:00 and 12:00 – 20:00 - reporting into the QA Supervisor.

As a QA Officer you will support the Batch Release process for Finished Goods, PCD and label checks, scanning and archiving as well as supporting TrackWise.  Working with a small busy team the role will be office based and require a meticulous eye for detail, strong knowledge of GMP and the use of Oracle and Microsoft Office.  

Key Responsibilities:

• Perform post-production GMP reviews of Finished Goods batch documentation
• Complete pre-production review of PCDs and product labels before issuance to production
• Oracle report generation
• Review and approval of final product Certificates of Analysis in accordance with the approved product specification.
• Documentation of non-conformities in TrackWise
• Support for investigations to support finished goods release
• Scanning and archiving documentation
• Support the continuous improvement program to drive quality, safety and process improvements.

Qualifications:

• GCSEs in English, Mathematics, Science or equivalent
• Good understanding of cGMP

• Experience of working in an office or cleanroom environment
• Excellent written and oral communication skills
• Meticulous attention to detail
• Excellent team work and problem solving skills
• Ability to manage priorities and work to set timeframes
• Excellent IT skills – MS Office, Outlook, Oracle
• Willingness to learn and drive process improvements

REQUIREMENTS:
• Professional communication skills both written and spoken
• Ability to manage multiple priorities in a dynamic environment
• Strong attention to detail and analytical problem-solving skills
• Effective interpersonal and communication abilities
• Demonstrated ability to work effectively with cross-functional teams
• Proficiency with Microsoft Office applications
• Ability to work various shifts as required
• Knowledge of root cause analysis and quality improvement tools
• Demonstrated ability to guide and develop team members
• Experience with clean room operations and gowning procedures preferred
• Ability to understand and interpret technical procedures and specifications