QA Specialist, Quality Notifications

Work Schedule

First Shift (Days)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

DESCRIPTION:
Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Assurance Specialist at Thermo Fisher Scientific Inc., you will have the unique opportunity to be a part of an elite team and contribute to the detailed execution of our quality assurance processes. This role is essential in ensuring that our products meet the highest standards and regulatory requirements, and the opportunity to directly impact patient care through quality oversight of critical products.

Key Responsibilities:

• Drive internal investigations, including product evaluation and process review, to determine the root cause of quality issues. You will collaborate with cross-functional teams to successfully implement corrective actions and ensure customer satisfaction.
• Implement and maintain procedures in strict compliance with 21 CFR Part 820 Quality System Regulations, ISO 13485 standards, and other applicable international standards.
• Monitor and document various metrics, including complaint/product handling, stability testing, and performance, and present them to the Quality Review Board and other relevant parties.
• Test products for microbial performance using ATCC organisms, providing timely and accurate responses to customer inquiries.
• Prepare written responses to quality notifications or inquiries from customers, demonstrating exceptional written communication skills.
• Lead issue review investigations to address concerns raised by customer complaints, ensuring that all issues are thoroughly addressed and resolved.
• Review quality documentation, such as device history records and processing records, to ensure compliance with internal policies and process requirements.
• Serve as an expert within Thermo Fisher Scientific for complaint/product issues, providing guidance and support to colleagues across the organization.
• Collaborate with customers and technical service representatives to effectively address and resolve any customer issues.
• Participate in development, maintenance, and monitoring of programs for compliance with the Quality Systems Regulations (QSR) and internal procedures.

REQUIREMENTS:
• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology
• Preferred Fields of Study: Biology, Microbiology or related scientific/technical field
• ISO 13485/FDA Lead Auditor certification beneficial
• ASQ certification (CQE, CQA) advantageous
• Strong knowledge of quality systems, cGMP regulations, and standards including ISO 13485, 21 CFR Part 820
• Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and change control
• Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
• Excellent documentation and technical writing skills for developing SOPs, protocols and reports
• Experience conducting internal audits and supporting external regulatory inspections
• Demonstrated ability to build consensus and collaborate across functions
• Strong verbal and written communication skills
• Ability to work independently while contributing effectively in team environments
• Strong attention to detail with analytical and problem-solving capabilities
• Experience with statistical analysis tools and quality metrics reporting
• Project management skills and ability to prioritize effectively