Quality Assurance/ Data Integrity SME
About The Position
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.
Requirements
- 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.
- 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.
Nice To Haves
- 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.
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.
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What This Job Offers
Career Level
Senior
