Quality Specialist II

Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you'll ensure compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. Working with cross-functional teams, you'll implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that enable our mission of making the world healthier, cleaner, and safer.

Day in the Life:

• Review and approve Standard Operating Procedures(SOPs), test methods, specifications, stability reports, and validation protocols and reports to ensure compliance with established quality standards and regulatory requirements
• Review and approve change controls, deviations, investigations, and CAPAs
• Assist in establishing, revising , and maintaining SOPs, including periodic reviews to ensure procedures remain accurate, current, and compliant with applicable requirements
• Maintain a thorough understanding of ICH guidelines, FDA regulations, and applicable quality standards. Apply this knowledge to support and justify quality-related decisions
• Review and approve stability protocols and reports
• Review and approve reference standard protocols and qualification data
• Apply critical thinking, technical expertise, and independent judgment to evaluate quality issues, resolve daily challenges, and make informed, risk-based decisions
• Independently prioritize and manage multiple assignments to meet operational deadlines
• Collaborate with other departments to streamline operations and create efficient solutions
• Communicate effectively with Project Management, Analytical Research and Development, and Quality Control Departments to support project deliverables, address quality concerns, and maintain alignment with business objectives
• Perform other duties as required to support departmental objectives, regulatory compliance, and overall business operations

• Advanced degree with no prior experience, or Bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or related GMP environment
• Preferred Fields of Study: Biology, Chemistry, Engineering, Life Sciences, or related scientific field
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements
• Experience with quality management systems and documentation (TrackWise, Documentum, or equivalent)
• Experience in deviation investigations, CAPA, change control, and root cause analysis
• Proficient in Microsoft Office suite and quality management software systems
• Technical writing and documentation skills
• Analytical and problem-solving abilities
• Clear verbal and written communication skills
• Ability to work independently and collaboratively in cross-functional teams
• Experience conducting internal audits and supporting external regulatory inspections
• Project management and organizational skills
• Physical requirements include standing/walking for extended periods and occasional lifting up to 25 lbs