Kelley Stephens
Bishopville,MD
Summary
Highly organized and self-motivated professional experienced in project management, team development and process improvement. Skilled in leading cross-functional teams while driving continuous improvement and compliance initiatives. Extensive experience in preparing and submitting regulatory documentation, including investigational writing, fact finding and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Proficient in and actively uses multiple database systems (Reliance, MEDS, SAP, Aera, Power BI).
Overview
23
23
years of professional experience
1
1
Certification
Work History
Quality Assurance Associate Director
Merck Animal Health
10.2019 - Current
- Oversee Product Quality Complaint system for the site, ensuring all complaints are investigated, quality approved and escalated as appropriate; Conduct monthly and quarterly metric and trend reports for site
- Prepare and manage regulatory health authority submissions including immediate notifications, one-time exemptions, and investigation summaries in use with Management Notification, Fact Finding, Recall and Health Authority Notification processes
- Serve as Alternate Liaison with the USDA for submissions and communications
- Strong understanding of cGMPs, Quality Management Systems (QMS) and Health Authority regulations
- Ensures permanent audit readiness; regulatory inspection support and monitoring
- Authors external observation responses for audit findings; Ensures all observation CAPAs are closed, and required evidence is submitted
- Serve as Quality Approver to ensure investigations are thorough and have identified robust CAPAs with defined effectiveness checks
- Drive compliance initiatives for the site by verifying accuracy and ensuring all completed OTIF (Annual Outline Review, Facility Document Review) working closing with Local and Global Regulatory Affairs
- Site lead for Event Revolution, routinely analyzing deviations and trends to develop strategies for target deviation reduction
- Extremely versed in Change Management Systems as Change Manager and/or Change Approver
- Site System Owner for Quality Systems & Organization and Material Management and Sub System Owner for Quality Governance, Periodic Quality Reviews, Health Authority and Escalation
- Review and submit product serials to USDA for market release
- Lead of Lots Released On Time (LROT) Improvement Project at site
- Train, develop and manage department staff for specific projects and ongoing quality needs; Including driving MPS initiatives for department.
Quality Assurance Manager
Merck Animal Health
03.2019 - 10.2019
- Created and ensure compliance with new seed/cell bank inventory system (~450 seeds on site)
- Accomplished multiple tasks within established timeframes.
Quality Control Senior Specialist
Merck Animal Health
11.2017 - 03.2019
- Manage, prioritize, and schedule Millsboro, DE select agent activities as Alternate Responsible Official
- Complete written reports, responses, and commitments to USDA
- Create and revise Standard Operating Procedures for select agent program.
Clinical Services Manager
Merck Animal Health
04.2012 - 11.2017
- Serve as Institutional Animal Care and Use Committee Chair and Administration Coordinator (Semiannual Reports, Annual Animal Numbers, Training)
- Completed A3s and RFCs to manage department capital projects
- Established annual budget with controls to prevent overages
- Ensure compliance against USDA, Select Agent, VMD and DNREC regulations
- Cross-trained existing employees to maximize team agility and performance
- Established and updated work schedules to account for changing staff levels and workloads
- Propelled continuous improvement projects.
Animal Use Supervisor
Merck Animal Health
01.2007 - 04.2012
- Coordinate and supervise daily operations of activities for product release testing.
Testing Specialist
Merck Animal Health
07.2002 - 01.2007
- Conduct Quality Control serial release testing.
Animal Care Technician II
Merck Animal Health
06.2001 - 07.2002
- Complete all aspects of animal husbandry, observation and record keeping.
Education
Bachelor of Science - Animal Science
Delaware Valley University
Doylestown, PA05.2001
Skills
- Project Management
- Problem-Solving
- Process Improvement
- Investigational Writing & Editing
- Data Collection & Verification
- Regulatory Compliance
- Regulatory Documentation
- Regulatory Inspections
- Audit Tracking
- Compliance
- Corrective Actions
- Routine Inspections
- Leadership
- Team Development
- Coaching and Mentoring
- Verbal and Written Communication
- Proficient in Word, Excel, SAP, Reliance, MEDS, AERA, Power BI
Certification
- LATG (Laboratory Animal Technologist)
- Lean Six Sigma Yellow Belt KATA
Affiliations
AALAS (American Association of Laboratory Animal Science)
Timeline
Quality Assurance Associate Director
Merck Animal Health
10.2019 - Current
Quality Assurance Manager
Merck Animal Health
03.2019 - 10.2019
Quality Control Senior Specialist
Merck Animal Health
11.2017 - 03.2019
Clinical Services Manager
Merck Animal Health
04.2012 - 11.2017
Animal Use Supervisor
Merck Animal Health
01.2007 - 04.2012
Testing Specialist
Merck Animal Health
07.2002 - 01.2007
Animal Care Technician II
Merck Animal Health
06.2001 - 07.2002
Bachelor of Science - Animal Science
Delaware Valley University
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