Single Use Technology Audit Lead, Quality Systems

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Join the Single Use Technology, Quality Management System team, at Thermo Fisher Scientific Inc., where you will work in a dynamic and collaborative environment. This is an onsite position in Logan Utah, Millersburg , Pennsylvania, Nashville, TN or Cramlington, UK​. Residency near either locations is required. No relocation assistance provided.

Discover Impactful Work:

Lead audits, drive improvement, ensure compliance with quality and regulatory standards as the Single Use Technology Audit Lead.

A day in the Life:

• Develop and maintain the annual network internal audit schedule
• Conduct internal audits and collaborate effectively with cross-functional teams
• Lead the network external audit program, ensuring risks are identified and communicated across the business
• Assist Customers with quality management system queries
• Manage the network desktop audit package to ensure it remains up to date.
• Maintain external audit procedures and associated documentation.
• Generate and manage metrics to monitor audit performance across the network.
• Support the Customer Quality Agreement process
• Apply Practical Process Improvement (PPI) to drive continuous improvement in the audit process.

Keys to Success:

Education

• Bachelor’s Degree in a scientific field or proven experience within Biotech/Pharma quality management systems

Experience

• Minimum of 2 years in a Quality Management System role
• Successfully delivering large and complex improvement initiatives
• Certified as a Lead ISO 13485 auditor.
• Expertise in GMP standards

Knowledge, Skills, Abilities

• Proven ability to participate in groups, manage deliverables and establish relationships
• Excellent written and oral communication skills: ability to communicate effectively with customers and compose and deliver outstanding presentations.
• Outstanding interpersonal skills, including collaboration and negotiation
• Experience in developing and managing project plans and priorities.

Physical Requirements / Work Environment

This position may require approximately 25% travel, both domestic and international. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.