Quality Specialist II

Thermo Fisher Scientific • Florence, SC

7d

About The Position

Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. The role ensures compliance with GMP standards, FDA regulations, and international quality requirements while supporting manufacturing operations across multiple product lines. The Quality Specialist II works with cross-functional teams to implement continuous improvement initiatives, conduct investigations, and maintain quality management systems.

Requirements

• Advanced degree with no prior experience, or a bachelor's degree with 2 years of experience in pharmaceutical/biotech manufacturing, quality assurance, or a related GMP environment.
• Knowledge of cGMP regulations, ISO standards (9001/13485), and international regulatory requirements.
• Experience with quality management systems and documentation, such as TrackWise, Documentum, or equivalent.
• Experience in deviation investigations, CAPA, change control, and root cause analysis.
• Proficiency in Microsoft Office 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.
• Physical ability to stand and walk for extended periods and occasionally lift up to 25 lbs.
• Must be legally authorized to work in the United States now and in the future without sponsorship.
• Must be able to pass a comprehensive background check, including drug screening.

Nice To Haves

• Preferred fields of study include Biology, Chemistry, Engineering, Life Sciences, or a related scientific field.
• Experience conducting internal audits and supporting external regulatory inspections.
• Project management and organizational skills.

Responsibilities

• Review and approve standard operating procedures (SOPs), test methods, specifications, stability reports, and validation protocols and reports to ensure compliance with 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 keep procedures accurate, current, and compliant.
• Apply knowledge of ICH guidelines, FDA regulations, and applicable quality standards to support and justify quality-related decisions.
• Review and approve stability protocols and reports.
• Review and approve reference standard protocols and qualification data.
• Use critical thinking, technical expertise, and independent judgment to evaluate quality issues, resolve daily challenges, and make risk-based decisions.
• Prioritize and manage multiple assignments to meet operational deadlines.
• Collaborate with other departments to streamline operations and create efficient solutions.
• Communicate 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 business operations.

Benefits

• Medical, dental, and vision benefits effective Day 1.
• Paid time off and designated paid holidays.
• Retirement Savings Plan.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level