What are the responsibilities and job description for the Quality Specialist III - Quality Auditor position at Thermo Fisher Scientific?
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Job Title : Quality Auditor
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Summary :
The Quality Auditor will be responsible for assigned customer audits, regulatory inspections, and internal audits in accordance with established quality assurance processes, standards, federal and global regulatory guidelines and / or client contractual obligations. This position reports to the Quality Compliance Manager.
Quality Auditor
- Independently completes all aspects of regulatory inspections, customer audits, and internal audits, including, but not limited to, scheduling, documentation preparation, SME coordination, hosting, follow-up responses, and audit closure.
- Ensures on-time completion of audit activities with demonstrated interpersonal skills.
- Interprets FDA and international regulations, Standard Operating Procedures, and company policies for regulatory compliance. Maintain continuous education of current regulatory requirements.
- Partners with area leaders and subject matter experts for audit activities. Provides audit and inspection training as needed.
- Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety Guidelines.
- Maintains the necessary compliance status required by company and facility standards.
Knowledge, Skills, Abilities
Education :
Experience :
We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!
