Tunnell Consulting is an employee-owned, life sciences management consulting firm. Known for solving complex problems in the life sciences, we support the mission and objectives of a variety organizations including biotech, pharma, the U.S. Government, foundations, public/private partnerships, investors, and emerging companies. The variety of clients and issues that we support give our team and our organization an ever-increasing breadth of experience to add to our deep industry and functional expertise. Headquartered in the Philadelphia area, we also have a presence in Washington DC, and Boston.
Quality Assurance / Data Integrity SME
One of our clients is seeking a Quality Assurance/ Data Integrity SME to perform work predominantly onsite. This is a 6-9 month contract. Our client resides in the southwest corner of Ohio and is located in the greater Cincinnati-Wilmington-Maysville geographic area. Local candidates preferred.
Position Summary
The Quality Assurance (QA) / Data Integrity SME is responsible for ensuring compliance with GMP regulations, data integrity requirements, and company quality standards. This role supports audits, investigations, CAPAs, and regulatory inspections while serving as a subject matter expert on data integrity (paper and electronic based) and FDA 21 CFR Part 11 requirements.
Key Responsibilities
Qualifications
Required Knowledge
Preferred
Ideal Candidate: A QA professional with strong auditing experience, data integrity expertise, knowledge of FDA 21 CFR Part 11, and a proven ability to lead investigations, present CAPAs, and drive compliance improvements.
Tunnell strives to hire and retain the most qualified talent. We believe that having employees with different backgrounds and capabilities contributes to the success of our business. To attract qualified applicants, Tunnell posts to a wide variety of job sites. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
With a strong focus on the life sciences industry, Tunnell Consulting designs and implements sustainable solutions that improve the operating performance of each unique client we serve. Integrating technical, process and organizational skills, our proven problem-solving methodologies enable life science companies to achieve optimal compliance and quality performance, operational excellence and organizational effectiveness. Since our founding in 1962, our experienced professionals, representing a wide range of scientific, technical, analytical and business disciplines, have worked with leading life sciences companies to achieve increased efficiency and measurable results that show up on the top and bottom lines. Our capabilities include: Cost Reduction, Operational Excellence, Business Transformation, Process Understanding, QbD, Technology Transfer, Quality and Regulatory Compliance and much more. The greatest measure of our success continues to be the high percentage of clients who repeatedly return to us when they expand, reorganize or encounter an organizational obstacle.