Sr QA Technician

Work Schedule

Environmental Conditions

Job Description

Position Summary

Become an integral part of the ambitious QA team at Thermo Fisher Scientific Inc. as a Quality Specialist I. This role is pivotal in ensuring our manufacturing processes are of world-class quality and strictly adhere to GMP requirements. Collaborate with a team driven to implement flawless quality systems and successfully meet corporate standards and regulatory compliance.

Responsibilities

• Ensure the safety message is lived throughout the organization, promoting a culture of safety.
• Coordinate document and record management systems; coordinate site document management requirements, including document printing, reconciliation, and archival.
• Ensure all documents follow approved instructions and that completed records are archived accurately.
• Coordinate site training and personnel qualification, improving GMP training modules.
• Ensure timely completion and efficiency checks of CAPAs.
• Manage corporate standards gap assessment, ensuring site compliance with regulatory requirements.
• Support and continuously improve the site self-inspection program, including developing annual plans, and performing periodic reviews and trend analyses.
• Coordinate inspection readiness activities, preparing the site for client and regulatory audits.
• Participate in audits, ensuring smooth execution and compliance.
• Adhere to and support the implementation of site data integrity systems.
• Complete any additional related tasks as assigned.

EHS

• Understand and ensure implementation of emergency procedures and safe work systems.
• Ensure compliance with environmental, health, and safety rules and prompt reporting and investigation of incidents.

Minimum Requirements/Qualifications

• Education: Diploma or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related field.
• Experience: 1-3 years of relevant quality experience in pharmaceuticals preferred. Fresh graduates with relevant qualifications may be considered.
• Proficiencies: Understanding of cGMP and regulatory compliance, strong communication and collaboration skills, problem-solving capabilities, and knowledge of quality risk management.