When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

LOCATION/DIVISION SPECIFIC INFORMATION

St. Louis, MO

HOW WILL YOU MAKE AN IMPACT?

Lead a multidisciplinary team of laboratory, operations, compliance, validation, quality, and engineering personnel to ensure all CGxP data is collected, protected, archived, preserved, and retrievable according to industry and regulatory guidelines. Ensure the Research/Quality Operations have awareness of Data Integrity as it relates to paper and electronic records and ensure good documentation practices for electronic and paper based data are in place. The position will coordinate and facilitate meetings with cross-functional groups to discuss data integrity. This position will be responsible for ensuring the site operates under applicable regulatory policies for documentation and data integrity/guidelines as well as striving for continuous improvement. The Data Integrity Compliance Officer is the point person during regulatory inspections for Data integrity and plays a major role in regulatory and customer audits to answer questions and demonstrate to auditors that necessary controls and required competencies are in place for Thermo Fisher Scientific to maintain its license to operate.

WHAT WILL YOU DO?

• Ensure all new equipment and instrumentation is assessed appropriately and validated for its intended use and existence, usage, and review of audit trails and 21CFR Part 11 and Annex 11 regulations.
• Communicate actions, compliance gaps, and commitments to respective areas, including the Site Director of Quality.
• Perform risk assessments and data process mapping to determine high risk equipment and audit trails and take appropriate action to bring into compliance. Assist in sourcing, assessing, and recommending instrumentation/equipment for purchase.
• Provide periodic training to site GMP personnel to ensure awareness and compliance with data integrity for both paper and electronic records, including inspector interaction and good documentation practices.
• Create/update procedures as necessary to ensure operations awareness and importance of regulatory requirements and expectations. Routinely evaluate regulatory inspection documents and update site procedures accordingly. Keep the site aware of industry trends.
• Create and execute Change Controls for instrumentation/equipment. Aid in establishing user requirements for equipment.
• Establish and lead a Surveillance program to audit all GMP facilities within the site for compliance to establish documentation and data integrity standards, practices, and procedures.
• Select and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures. Serve as an advisor to Research/Quality Operations for Data Integrity matters. Represent the company as a subject matter expert during regulatory and customer audits for Data Integrity. Meet with vendors to discuss software capabilities in regards to 21CFR Part 11 compliance.

HOW WILL YOU GET HERE?

EDUCATION:

• Bachelor’s Degree in Science, Engineering, or related fields.

EXPERIENCE:

• At least 7 years of experience in a regulated industry or 5 years with related technical knowledge including data integrity related to computer systems / data related to manufacturing equipment, QC instruments, and support equipment/systems.
• Experience in data review, 21CFR Part 11 instrumentation compliance as well as writing and reviewing investigations within TrackWise.
• Proficient in the application of 21CFR Part 11 and Annex 11 regulations as well as stay current with updates to these regulations.

KNOWLEDGE, SKILLS, ABILITIES:

• Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Effective written, interpersonal, and presentation skills.
• Ability to work on multiple projects simultaneously.

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.

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.

As the world’s leader in serving science, Thermo Fisher Scientific's professionals develop critical solutions—and build rewarding careers. They help customers in finding cures for cancer, protecting the environment, making sure food is safe, and so much more. When you #StartYourStory with Thermo Fisher, you are guaranteed meaningful work - both personally and professionally.