Quality Assurance Specialist II

Thermo Fisher Scientific • Millersburg, PA

2d • Onsite

About The Position

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. This position will be based at the Thermo Fisher Scientific site located in Millersburg, PA. Be part of a fast-growing manufacturing site committed to operational excellence across manufacturing and the supply chain. This role is instrumental in driving year-over-year double-digit growth through support of critical quality and operational initiatives. At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Requirements

• HS Diploma
• Minimum of 2+ years of experience in a Quality Management System environment.
• Experience working collaboratively in a team setting.
• Proven ability to deliver high-quality work under tight deadlines.
• Ability to understand various manufacturing processes and quality processes.
• Excellent written and verbal communication skills.
• Ability to effectively interact with and influence all levels of the organization.
• Experience developing and implementing procedures.
• Strong investigative, critical thinking, and problem-solving skills.
• Proficiency with statistical tools (e.g., Excel, Minitab) and Microsoft Office Suite.
• Strong attention to detail.
• Working knowledge of scheduling, meeting documentation, action tracking, and follow-up communications.
• Positive attitude with strong interpersonal and communication skills.
• Ability to prioritize and manage multiple projects simultaneously.
• Ability to influence without direct authority.
• Proven ability to build credibility and maintain strong professional relationships across all organizational levels.
• Proficiency in Microsoft Office Applications.
• Ability to travel (<10%).

Nice To Haves

• Associates Degree
• Strong working knowledge of ISO 13485.

Responsibilities

• Establish, manage, and continuously improve a risk-based internal Quality Management System (QMS) Audit Program.
• Conduct internal audits and prepare, review, and approve audit reports for key QMS processes in accordance with the Quality Assurance Manual and Audit SOPs.
• Manage CAPA and TrackWise records related to audit activities.
• Analyze, track, and trend audit data to drive process improvements and program performance.
• Coordinate and schedule internal audit activities, partnering cross-functionally with process owners.
• Monitor and manage audit observations, ensuring timely CAPA execution and adherence to commitments.
• Maintain oversight of the site Environmental Monitoring Program, including: Surveillance Monitoring of ISO 7 & 8 Suites Compendial Testing (Endotoxin, Particulate, Bioburden) Cleanroom Risk Assessments Annual Cleanroom Certification
• Perform additional duties and special projects as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED