Compliance Auditor

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. Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

How will you make an impact?

You will support on-site client, regulatory and internal audits. You will manage audit observations and CAPA’s. You will provide administrative support to the Compliance department and maintain documents and prepare packages to support regulatory requests.

What will you do?

Essential Functions

• Supports on-site client, regulatory and internal audits.
• Manage audit observations and CAPA’s.
• Provides administrative support for ongoing Compliance projects.
• Supports Vendor Management Program.
• Supports maintenance of Table A.
• Assists with document and records management.
• Other duties as assigned.

How will you get there?

Education:

• Minimum College/Technical School Diploma in pharmaceutical manufacturing, science or related field.
• Bachelor of Science (B.Sc.) in Chemistry, Biology, Life Sciences preferred.

Experience:

• A minimum of 3 years of relevant experience in a GMP environment, in the pharmaceutical or related industry is required.
• Experience working with clients and Regulatory agencies is preferred.
• Working with internal or external partners to drive compliance, CAPA completion to audit findings, and/or performance improvement is an asset.

Competencies:

• Good knowledge of GMP, HPFBI, FDA and SOP requirements.
• Knowledge of applicable Quality Standards, related Regulatory requirements and best practices.
• Knowledge of Table A requirements is an asset
• Attention to detail.
• Excellent interpersonal, organizational, oral and written communication skills.
• Proficiency in Microsoft Office Suite (Word and Excel).
• Proficiency in Trackwise is an asset.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

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.