Job Description
Job Description
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
- Ensure compliance with GMP, data integrity, and regulatory requirements.
- Conduct and support internal, supplier, and regulatory audits.
- Serve as an auditor or audit observer during inspections and assessments.
- Investigate quality issues, deviations, and data integrity concerns.
- Develop, present, and track Corrective and Preventive Actions (CAPAs) through closure.
- Perform root cause analyses and recommend effective solutions.
- Review electronic records and audit trails for compliance.
- Support inspection readiness and regulatory interactions.
- Provide training and guidance on quality systems and data integrity principles.
- Prepare and deliver presentations on audit findings, CAPAs, and compliance activities.
Qualifications
- Bachelor's degree in a scientific, technical, or related field.
- 3+ years of Quality Assurance and Compliance in a regulated industry.
- 1+ years of Data Integrity experience in a regulated industry.
- Experience as an auditor and/or audit observer.
- Proven experience leading investigations and CAPA resolution.
- Strong presentation, communication, and problem-solving skills.
Required Knowledge
- FDA 21 CFR Part 11 (Electronic Records and Electronic Signatures).
- Data Integrity principles (ALCOA/ALCOA+).
- GMP regulations and Quality Management Systems (QMS).
- CAPA, deviations, change controls, and risk assessments.
- Audit trail review and computerized system compliance.
Preferred
- ASQ Certified Quality Auditor (CQA) or similar certification.
- Experience with systems such as TrackWise, Veeva, LIMS, Empower, SAP, or other validated GxP systems.
- Experience supporting FDA or other regulatory inspections.
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.