Quality Specialist II
About The Position
Join Thermo Fisher Scientific as a Quality Specialist II and contribute to global healthcare and scientific advancement. In this role, you will 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 will implement continuous improvement initiatives, conduct investigations, and maintain quality management systems that support the company's mission of making the world healthier, cleaner, and safer. The position is a standard Monday–Friday office role. It requires applying quality and regulatory knowledge, independent judgment, and risk-based decision-making to support operations and project deliverables.
Requirements
- Advanced degree with no prior experience, or a bachelor's degree with 2 years of experience in pharmaceutical or 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.
- 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 pass a comprehensive background check, including a 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 for compliance with quality standards and regulatory requirements.
- Review and approve change controls, deviations, investigations, and corrective and preventive actions (CAPAs).
- Assist in establishing, revising, and maintaining SOPs, including conducting periodic reviews to ensure procedures remain accurate, current, and compliant.
- Maintain knowledge of ICH guidelines, FDA regulations, and applicable quality standards, and apply it 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 informed, risk-based decisions.
- Independently prioritize and manage multiple assignments to meet operational deadlines.
- Collaborate with other departments to streamline operations and develop efficient solutions.
- Communicate with Project Management, Analytical Research and Development, and Quality Control 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.
Benefits
- Medical, dental, and vision benefits effective Day 1.
- Paid time off and designated paid holidays.
- Retirement savings plan.
- Tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
