KRISTEL BLAIR
Schertz,TX
Summary
Versatile Senior Quality Assurance Specialist skilled in regulatory compliance, data management, and internal auditing. Combines experience in QA program leadership with a strong commitment to quality and safety in clinical research, fostering collaboration among clinical and operational teams.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Quality Assurance Specialist
Tandem Intermediate LLC
, US
07.2025 - 12.2025
- Lead the development, implementation, and enhancement of QA programs across multiple research sites.
- Maintained expert-level understanding of FDA regulations, ICH-GCP guidelines, and evolving industry standards.
- Served as lead liaison during sponsor, CRO, or regulatory authority inspections (e.g., FDA).
- Planned and conducted internal audits, mock inspections, and audit readiness initiatives.
- Ensured timely and accurate responses to audit findings and implemented follow-up CAPAs.
- Advised senior leadership on regulatory trends and risk mitigation strategies to bolster compliance efforts.
- Assisted with creation, revision, and review of Standard Operating Procedures to ensure regulatory alignment.
- Oversaw protocol compliance reviews, eligibility verifications, and source documentation for accuracy and completeness.
- Mentored junior QA staff and trained clinical and operations teams in QA best practices to enhance overall quality assurance capabilities.
- Collaborated with clinical, regulatory, and operational teams to embed quality into all phases of research.
- Monitored data trends, conducted gap analyses, and presented findings to senior leadership, facilitating informed decision-making.
- Provided on-site support for audits, training, and quality assessments across clinic locations.
Quality Assurance Specialist
Careaccess research
, US
07.2022 - 03.2025
- Ensured high integrity of data and patient safety at the research site through quality assurance review.
- Conducted internal audits to review study-specific regulatory binders and documents to ensure all documents are appropriately completed, submitted, and maintained per GCP standards.
- Tracked quality assurance audits and analyzed site metrics to identify areas for improvement.
- Coordinated and supported on-site audits conducted by external providers and regulatory agencies.
- Hosted FDA inspections.
- Prepared reports to communicate the outcomes of quality activities to appropriate company stakeholders.
- Executed yearly audit plan.
- Developed and distributed specific audit plans to align company stakeholders with quality objectives.
- Identify, develop, and implement process improvements.
- Interpreted and implemented quality assurance standards and procedures.
- Referred colleagues to 21 CFR and ICH GCP E6 R2/R3 guidelines for compliance.
- Provided support to the Quality Department through the administration and maintenance of quality systems, programs, and processes.
Quality Control Specialist
Endeavor clinical trials
San Antonio, US
01.2021 - 07.2022
- Performed Quality Control to maintain audit and inspection readiness of studies to include regulatory documents.
- Audited internal processes, ensuring compliance with quality standards.
- Identified and implemented process improvements, enhancing quality control measures.
- Ensured studies adhere to guidelines and regulations set by federal, state, and local health departments.
- Demonstrated decision-making and scientific problem-solving based on data and risk management principles.
- Know and refer colleagues when applicable to 21 CFR and ICH GCP E6 R2.
- Has working knowledge of clinical research concepts, FDA regulations and ICH guidelines regarding drug development phases, GCP/clinic SOPs, and individual protocols.
Pharmacy Quality Coordinator
Worldwide clinical trials
San Antonio, US
01.2018 - 01.2021
- Ensured quality and completeness of dose labels, drug accountability forms, retention log forms, dispensation forms, pharmacy compounding manuals, manufacturing batch records, and other pharmacy documentation.
- Monitored drug dispensation, compounding, and manufacturing processes to ensure compliance with work instructions, standard operating procedures, and regulatory guidelines.
- Conducted Quality Control audits on 100% of pharmacy data during study conduction to ensure quality work was being performed with integrity by WCT staff.
- Reviewed and updated Work Instructions and SOPs for the pharmacy department.
- Resolved queries and findings in pharmacy paperwork from quality assurance department audits to meet clinic timelines.
- Knowledge of the clinical research process, including Good Clinical Practices, informed consent process, drug accountability procedures, and IRB submission and reporting.
- Able to navigate, operate, and monitor internal audit system daily.
Pharmacy Technician
Cvs pharmacy
Cibolo, US
06.2016 - 06.2018
- Prioritized script filling and adjudicated scripts at customer drop-off, ensuring customers understood costs and insurance coverage, expediting processing time.
- Provided outstanding customer service, prioritizing customer needs and displaying genuine care and empathy in all interactions to ensure customer satisfaction.
- Managed pharmacy inventory: checked stock levels, anticipated medication needs, expedited orders, verified deliveries, and removed expired drugs.
- Maintained pharmacy records in compliance with HIPAA regulations, facilitating smooth insurance and regulatory audits.
- Trained new pharmacy technicians, ensuring customer service standards were exceeded.
- Maintained a safe and clean pharmacy by complying with procedures, rules, and regulations.
Pharmacy Technician
Platinum business corporation
Randolph AFB, US
08.2017 - 01.2018
- Performed a full range of pharmacy technician procedures while caring for our Military Members, their Families, and our Retired Military Veterans.
- Fulfilled pharmaceutical dispensing duties, ensuring accurate filling of outpatient prescriptions, timely refills, and precise order entry in databases to maintain service quality.
- Utilized information consultation duties to support new and refill prescriptions, address patient and physician requests, monitor drug interactions, and report adverse drug reactions for patient safety.
- Executed quality improvement duties by performing drug storage inspections, reviewing expired supplies, and documenting errors and workload to enhance pharmacy operations.
- Completed supply process duties including placing new orders, stocking/restocking shelves.
Education
Certificate - Clinical Quality Assurance Auditor
Barnett international
UsCertificate - Sterile Compounding and Aseptic Technique
Austin community college
Austin, TXDiploma - Pharmacy Technician
Brightwood college
San Antonio, TXCertificate - Health Information Specialist/ Medical Billing and Coding
Hallmark college
San Antonio, TXSkills
- FDA regulations and compliance
- GCP and ICH-GCP guidelines
- Quality assurance practices
- SOP development and implementation
- CAPA management
- Internal audit processes
- Audit planning strategies
- CTMS and Docusign
- ZenQMS and TrackWise
- CRIO system management
- Florence and Complion integration
- Real-time data management
- LMS and training development
- Microsoft Office Suite
- SharePoint collaboration tools
- Problem solving and adaptability
- Communication skills and mentorship
- Quality assurance practices
Certification
Certified Quality Assurance Auditor, Barnett International
Accomplishments
- Quality Audit Excellence, Completed 150 quality audits with 98% on-time delivery rate.
- Audit Efficiency Improvement, Reduced audit preparation time by 40% with streamlined processes.
- FDA Inspection Success, Hosted 4 successful FDA and 1 DEA inspections with zero critical findings.
Languages
English, Native
Timeline
Senior Quality Assurance Specialist
Tandem Intermediate LLC
07.2025 - 12.2025
Quality Assurance Specialist
Careaccess research
07.2022 - 03.2025
Quality Control Specialist
Endeavor clinical trials
01.2021 - 07.2022
Pharmacy Quality Coordinator
Worldwide clinical trials
01.2018 - 01.2021
Pharmacy Technician
Platinum business corporation
08.2017 - 01.2018
Pharmacy Technician
Cvs pharmacy
06.2016 - 06.2018
Certificate - Clinical Quality Assurance Auditor
Barnett international
Certificate - Sterile Compounding and Aseptic Technique
Austin community college
Diploma - Pharmacy Technician
Brightwood college
Certificate - Health Information Specialist/ Medical Billing and Coding
Hallmark college