Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Warehouse

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.

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.

Key Responsibilities:

• Overseeing the management of Standard Operating Procedures (SOPs) and maintaining meticulous Document Control through our electronic document management system.
• Thoroughly reviewing and providing approvals for TrackWise quality records to facilitate change management and continuous improvement through deviation investigation.
• Conducting comprehensive Quality reviews of change controls, safeguarding consistency, quality, and compliance.
• Managing status control for products/materials on inventory systems, always ensuring accuracy and compliance.
• Management of training items and content on the learning management system to impose training compliance for site.
• Management of supplier assessments to uphold our high standards of quality across the supply chain.
• Ensuring unwavering adherence to ISO9001, our company's QMS, and all relevant regulations and standards.
• Guaranteeing compliance with MHRA regulations to secure the retention of MIA(IMP) and MS licenses.
• Ensuring compliance with HTA regulations, vital for retaining our HTA license.
• Management of document storage by taking on archivist responsibilities to ensure data retention is compliant to data integrity requirements.
• Providing quality support during Client audits and Internal Audit Programs when needed.
• Delivering comprehensive training and competency assessments to fellow QA staff, leveraging your expertise in at least one subject area.
• Thoroughly inspecting and approving completed operational documentation for ALCOA compliance and adherence to Good Documentation Practices.
• Undertaking additional QA-related tasks assigned by the QA Supervisor to ensure comprehensive compliance.

• Carrying out Quality Control functions as required, maintaining our commitment to quality at all stages.

• Willingness to travel as necessary to fulfil the responsibilities of the role.

• Flexibility to perform off-site work when required to support operational demands.

REQUIREMENTS:
• Minimum of 1 year of experience in pharmaceutical quality assurance or related GMP environment
• Possesses a degree level education or equivalent in life sciences or related scientific field
• Knowledge of GMP regulations and quality systems
• Expertise in batch record review, deviation investigations and CAPA management
• Proficiency in quality documentation systems (e.g. TrackWise, Documentum)
• 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
• Project management and organisational capabilities
• Experience supporting regulatory inspections and customer audits
• Demonstrated ability to work effectively with cross-functional teams
• Proficiency with Microsoft Office applications
• Knowledge of root cause analysis and quality improvement tools
• Ability to understand and interpret technical procedures and specifications