Senior Quality Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office, Warehouse

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.

Position Summary

The Senior Quality Specialist is responsible for supporting quality assurance and quality control activities to ensure compliance with cGMP standards, company policies, and applicable regulatory requirements. This role plays a key part in maintaining the quality management system and ensuring the integrity of clinical trial supply chain operations.

Key Responsibilities

• Ensure compliance with corporate policies, cGMP requirements, and applicable local and international regulations.

• Provide quality guidance and support to internal stakeholders and clients.

• Manage document control processes and maintain quality system documentation.

• Conduct internal and supplier audits and support regulatory, client, and external inspections.

• Review and approve production batch records, label printing records, and related documentation.

• Perform in-process inspections to ensure compliance with quality standards.

• Investigate and manage quality events, including deviations, complaints, and non-conformances, and implement appropriate corrective and preventive actions (CAPA).

• Oversee quality compliance for controlled-temperature shipments and material release activities.

• Review and approve component and material specifications.

• Develop, maintain, and improve Standard Operating Procedures (SOPs) and quality processes.

• Support QA/GMP training programs and promote a culture of quality and compliance.

• Participate in continuous improvement initiatives to enhance quality systems, operational efficiency, and regulatory compliance.

• Perform other duties as assigned by management.

Job Requirements

• Bachelor's degree in Life Sciences or a related scientific, medical, or healthcare discipline.

• Relevant experience in quality assurance within the pharmaceutical, medical device, healthcare, or life sciences industry.

• Strong organizational skills with the ability to manage multiple priorities and meet deadlines.

• Strong analytical and problem-solving skills, with the ability to make sound decisions within established guidelines and procedures.

• Ability to work independently while collaborating effectively within a team environment.