Job Description

The Quality Specialist at Thermo Fisher Scientific Inc. plays a crucial role in maintaining and enhancing our Quality Management System (QMS). This is an exceptional opportunity to join a dynamic team dedicated to ensuring flawless execution of quality compliance activities. The successful candidate will determine the efficiency of our site's quality compliance and uncover opportunities for continuous improvement. This role involves ensuring timely delivery of commitments to both regulatory bodies and clients, effectively mitigating quality risks. This position also leads the deployment of corporate guidelines at the site level, handles product quality reviews, document control, training, supplier management, and data integrity. Mentor team members and build a collaborative network of colleagues to achieve world-class results.

Responsibilities

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Author and review relevant procedures and SOPs across functional teams. Prioritize safety as a fundamental goal throughout the organization. Configure and maintain QMS systems (e.g., TrackWise, eDMS, SFLMS) to support GxP compliance, authoring SOPs and Work Instructions. Coordinate the site change control system, ensuring all changes with potential product quality impacts are thoroughly evaluated and controlled. Manage the site CAPA system, crafting efficient actions, ensuring timely completion, and coordinating effectiveness checks. Conduct site-level corporate standards gap assessments to ensure compliance with regulatory requirements. Manage document and record management systems, overseeing effective execution and compliance with site requirements. Lead the development and execution of GMP training systems, creating training modules and annual plans. Develop annual product quality review plans, perform reviews, and implement CAPAs. Complete the site self-inspection program by developing annual plans, conducting inspections, and performing trend analysis. Ensure site readiness for client and regulatory audits, participating in hosting and managing responses to audit findings. Support the site management review process, collecting and analyzing quality data, and driving continuous improvement. Coordinate the site supplier management program, managing Quality Agreements, supplier change control, and participating in supplier evaluations. Lead and support Practical Process Improvement (PPI) activities related to QMS projects. Maintain the site data integrity system, ensuring efficient processes are in place. Perform and complete other related duties as assigned by the company.

Education

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Bachelor's Degree or equivalent experience in Life Sciences, Chemical/Biochemical Engineering, or a related scientific area.

Experience

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5-8 years of relevant quality experience in the pharmaceutical industry preferred. Experience with Quality Management Systems, specifically TrackWise. Experience in biologics and aseptic training is an asset. Strict experience in site data integrity management is essential.

Proficiencies

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Practical knowledge of cGMP and regulatory compliance. Strong critical thinking and effective communication. Proven coordination and teamwork skills. Ability to lead executions and achieve results. * Excellent problem-solving skills with a focus on continuous improvement and quality risk management.