Quality Assurance Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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.

Location/Division Specific Information

This position will be based at the Thermo Fisher Scientific site located in Millersburg, PA.

How will you make an impact?

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.

What will you do?

• 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.

How will you get here?

Education

Minimum Requirement: HS Diploma

Preferred: Associates Degree

Experience

• 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.

Preferred Experience

• Strong working knowledge of ISO 13485.
• 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.

Knowledge, Skills, Abilities

• 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%).

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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.