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.
Location: Cincinnati, OH - 2110 East Galbraith Road
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.
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Quality Compliance
Responsible to initiate and maintain GMP questionnaires with vendors.
Coordinate with quality, procurement, operations, and R&D globally to perform vendor audit activities.
Quality Agreements: initiation, review and issuance for Commercial and Development Clients.
Quality Agreements database periodic review to perform periodic reviews as identified.
Knowledge, Skills, Abilities
Clearly and accurately communicates in written and verbal form.
Applies excellent problem-solving skills with a logical approach to resolutions.
Strong decision-making skills.
Ability to prioritize multiple ongoing activities, and to prioritize tasks.
Outstanding attention to detail and organizational skills.
Highly effective verbal and written communication skills at all levels.
Excellent interpersonal skills to establish and maintain effective working relationships with employees and clients, including tact to handle critical matters.
Ability to work in a fast-paced environment.
Ability to maintain and manage high degree of confidentiality.
Education:
Bachelor of Science (B.Sc.) is preferred, or 4+ years of validated experience in GMP, GDP compliance and regulatory within the pharmaceutical industry.
Experience:
3+ years in Pharmaceutical Industry preferably within the Quality Compliance, QA, Engineering, or Project Management.
Extensive knowledge of GMPs, GDPs and Regulatory Affairs.
Experience working with various clients is preferred
Ability to work in a fast paced environment with changing priorities
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you!
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!
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!
