Dana Mitchell
Temple,TX
Summary
Proven Quality leader with 20+ years of experience in pharmaceutical manufacturing. Demonstrated expertise in optimizing production and quality operations, driving continuous process improvements, and developing cross-functional solutions. Adept at standardizing procedures to ensure consistent performance, regulatory compliance (FDA 503B, cGMP), and high-quality outcomes. Recognized for bridging technical documentation with execution on the floor, developing staff, and supporting facility-wide efficiency initiatives.
Overview
20
20
years of professional experience
Work History
Manager, Corporate Investigations and Lot Disposition
QuVa Pharma
01.2024 - 01.2025
- Managed 4 investigators assigned to a caseload of multi-site investigations, ensuring accurate root cause analysis and timely closures that maintained compliance with regulatory standards.
- Managed Corporate Change Control program, reducing aged backlog by 44% within 120 days.
- Led the Change Control Review board, a cross-department group discussion for complex Change Controls, ensuring a comprehensive plan prior to initiation.
- Developed and presented Investigation and Change Control KPIs to Director and C-suite levels.
- Leveraged data to recommend corrective action, post-investigation improvement and support strategies, including policy changes to address issues identified during investigations.
Manager, Quality Systems
QuVa Pharma
01.2020 - 01.2024
- Ensured site complied with the Current Good Manufacturing Practices (21CFR Parts 210, 211).
- Led site audit readiness and assisted with audit preparation, regulatory inspections, and customer audits, serving as a subject matter expert (SME) during regulatory audits (FDA, National Association of Boards of Pharmacy (NABP), Texas Department of State Health Services, DEA, California Board of Pharmacy).
- Managed Quality Management System including Annual Product Reviews (APRs), CAPAs, Change Controls, Deviations, Incident Reports, Quality Holds, Self-Inspections, document control, and training.
- Designed and implemented site-level KPIs, consistently maintaining 95%+ compliance rate across core metrics.
- Led continuous improvement projects to streamline document workflows and enhance operational execution.
- Reviewed and approved Master Batch Records, Stability protocols and reports, investigations, SOPs, Change Controls, CAPAs and Quality Holds.
- Worked with senior management to reduce errors on the manufacturing floor, dropping site incident rate by 10%.
Manager, Quality Assurance Lot Disposition
QuVa Pharma
01.2016 - 01.2020
- Ensured all raw materials, Active Pharmaceutical ingredients (API) and finished goods met all safety, quality and release standards.
- Directed final batch record review and disposition of commercial pharmaceutical lots in a repackaging and sterile manufacturing environment.
- Reduced batch release cycle time by 20% by streamlining the QA review process and improved documentation practices.
- Investigated manufacturing deviations, out-of-specification (OOS) results, and laboratory investigations, leading to closure.
- Supported FDA/regulatory inspections and internal and customer audits, acting as SME for lot disposition.
Manager, Quality Control
QuVa Pharma
01.2015 - 01.2016
- Led a team of 8 technicians, achieving 98% on-time release for parenteral dosage forms.
- Oversaw raw material and sterile product release testing, outsourced lab coordination, and internal team performance.
- Managed stability and environmental monitoring programs and supported test specification development.
- Performed quality label review and approval for commercial Finished Goods.
- Completed lab investigations for site testing out-of-specification results.
Manager, Quality Control
Unique Pharmaceuticals
01.2014 - 01.2015
- Managed quality testing programs for sterile products, including USP and USP testing, potency analysis and raw chemical testing.
- Led QC investigations and root cause analysis to support product integrity and compliance.
- Collaborated with cross-departmental team for new product development—creating test plans, assigning BUDs, and establishing product specifications.
- Developed and managed Skip-Lot testing program and Defective Component program.
- Led process and lab documentation improvements to increase testing throughput and reduce redundancies.
Supervisor, Quality Assurance
Unique Pharmaceuticals
01.2011 - 01.2014
- Supervised QA Analysts daily operations, provided training, performance reviews and mentorship, while ensuring compliance with safety and quality standards.
- Coordinated quality lab daily testing schedule of parenteral drug products including raw materials, sterility testing, endotoxin testing and outsourced potency testing.
- Responsible for maintaining laboratory inventory and equipment maintenance.
- Drove process improvements and partnered with production to boost throughput using lean manufacturing methods.
- Maintained compliance with Good Documentation Practices through regular documentation review and approval and reduced documentation redundancy across QA/QC workflows to create a more efficient lab operation.
- Obtained certification as an ISO 9001:2008 Quality Management Systems Lead Auditor.
Lead Technician / Certified Pharmacy Technician
Unique Pharmaceuticals
01.2005 - 01.2011
- Supported sterile and non-sterile compounding and repacking operations under USP 795/797.
- Conducted inventory checks, repack labeling, and collaborated with production and QA teams.
- Led team of 6 technicians, including training, daily scheduling and workflow optimizations and served as back-up to manager during time off.
- Operated and maintained lab equipment such as balances, pH meters, and repeater pumps per established SOPs.
Education
Bachelor of Science - Biology
University of Mary Hardin-Baylor
Belton, TX2005
Associate of Arts -
Temple College
Temple, TX2003
Skills
- Regulatory Compliance (21 CFR Parts 210, 211, FDA 503B, cGMP)
- KPI Development & Continuous Monitoring
- Investigations & Data-Driven Root Cause Analysis
- Team Coaching & Performance Development
- CAPA, Change Control, Deviations, Regulatory & Customer Readiness Audit
- Lean Manufacturing/Process Improvement
- Microsoft Office Suite
- Quality Management Systems (QMS)
- SOP Development & Procedure Standardization
- Cross-Function Collaboration
Timeline
Manager, Corporate Investigations and Lot Disposition
QuVa Pharma
01.2024 - 01.2025
Manager, Quality Systems
QuVa Pharma
01.2020 - 01.2024
Manager, Quality Assurance Lot Disposition
QuVa Pharma
01.2016 - 01.2020
Manager, Quality Control
QuVa Pharma
01.2015 - 01.2016
Manager, Quality Control
Unique Pharmaceuticals
01.2014 - 01.2015
Supervisor, Quality Assurance
Unique Pharmaceuticals
01.2011 - 01.2014
Lead Technician / Certified Pharmacy Technician
Unique Pharmaceuticals
01.2005 - 01.2011
Bachelor of Science - Biology
University of Mary Hardin-Baylor
Associate of Arts -
Temple College