JOB DESCRIPTION

Position Summary:
Join Thermo Fisher Scientific Inc. as a Lead QA Technician. Working a rotating 7 day a week shift pattern, you will be responsible for support quality systems, regulations, and the Quality Manager.

MINIMUM REQUIREMENTS/QUALIFICATIONS:

• Degree or equivalent experience in relevant subjects or at least 1 year of GMP experience.
• High degree of accuracy and attention to detail.
• Ability to interpret general procedures and regulations.
• Strong problem-solving skills and the ability to present information effectively.
• Proficient in MS Office and capable of mastering clinical trial database systems.
• Excellent verbal and written communication skills.
• Proven teamwork skills and the ability to operate under pressure.
• Employment is subject to a 10-year history screening for criminal records, qualifications, previous employment, and credit history.
• Proficient in English.

• Manage SOPs, including Document Control as Coordinator on eDMS.
• Review and approve Trackwise QRs including CAPAs, deviations and complaints
• Draft & approve operational documentation.
• Perform quality reviews of change controls and status control of products/materials.
• Manage items and content on SFLMS and conduct supplier assessments.
• Ensure compliance with our QMS and applicable regulations/standards.
• Assure adherence to EU GMP and IGJ regulations to maintain site licenses.
• Perform duties as an approved Archivist, verifying quality tasks.
• Support client audits and internal audit programs as needed.
• Provide training and proficiency assessments.
• Check operational documentation for ALCOA+ and Good Documentation Practices.
• Perform QA related tasks assigned by the site Head of Quality.
• Support QC incoming inspection and disposition activities.
• Perform Quality Control related tasks as required.
• Travel as the need arises and perform off-site work when vital.