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 is a remote based role that will require up to 30% travel within the MidWest/Southwest region as needed (for projects/audits). The ideal candidate will live within the MidWest/Southeast near one of the following cities:
Asheville NC, Pittsburgh PA, West Palm Beach FL, Marietta OH, Madison WA
How will you make an impact?
Unity Lab Services (part of Thermo Fisher Scientific) is looking for a highly motivated Quality Management Specialist with extensive experience to develop, support and sustain our Quality Management System for our North America Operations. The candidate must have exceptional drive, leadership and communication skills to harmonize our business to meet the compliance standards of ISO 9001 and the applicable elements of FDA’s 820 Quality System Regulation. The role will include expertise in a wide variety of quality functions along with providing regulatory guidance and expertise to our organizational team leaders to ensure our business and Quality Management System is proactive, effective and providing repeatable results.
What will you do?
- Support the business by continually improving the current Quality Management System for compliance to local, federal, and ISO regulations.
- Function as a strong Quality liaison to other functional departments, by providing meaningful quality support and ensuring productive cross-functional communication
- Collaborate and or support our functional leaders to develop effective quality procedures to meet compliance requirements and/or provide solutions to ensure a proactive quality model is in place.
- Perform a variety of quality reviews and approvals related to the document management process, including facilitating organizational compliance to the training matrix program.
- Lead and perform internal audits as needed.
- Lead role to facilitate business integrations into the Quality Management System (inter-divisional or new acquisitions) for readiness state prior to target audit cycle.
- Lead, review and approve Quality Issue Reviews or CAPA investigations performed by the functional staff to ensure that corrective action plans are thorough, complete and timely.
- Work with process owners to fully understand and provide guidance on appropriate investigation root cause, containment, corrective and preventative actions are thoroughly addressed to assure repeat deviations do not occur.
- Develop and report quality metrics as needed for score cards and quality review meetings.
- Provide functional support, oversight and enforcement of local and corporate record retention policies to ensure continued compliance.
- Sustain and support the complaints management system as needed
- Participate in quality improvement projects and tasks as assigned by the Quality Manager.
- Review and approve customer quality survey forms and quality agreements to accurately reflect our quality scope and commitments
How will you get here?
- Bachelor’s degree required
- 3-5+ years applied experience of implementing ISO9001
- 3-5+ years of audit experience
- Applied experience in PPI tools and Lean techniques (Investigations, Root Cause, Containment activities)
- An experienced team builder with ability to work collaboratively with various departments to identify and implement solutions to address quality/compliance issues
- Experience in development and authoring of quality procedures, work instructions and forms.
- Experience leading and rolling out projects and updates to the organization
Knowledge, Skills, and Abilities:
- High degree of independence, self-motivated, self-drive and discipline to assure tasks are on completed on time
- Ability to work well in a matrix environment, the ability to multi-task, ability to solve practical problems and deal with a variety of changing situations
- Use of Microsoft Word, Excel, PowerPoint, Outlook and Visio
- Excellent written, communication and strong critical thinking skills
- PPI or lean experience - Preferred
- ASQ Certification or Equivalent - Preferred
- 3-5 years of Lead Auditor experience w/ certification - Preferred
- Experience with using MasterControl Quality Management Software - Preferred
At Thermo Fisher Scientific, each one of our 65,000 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.