Sheila Casterline
Weyers Cave
Summary
Dynamic quality assurance leader with extensive experience at Merck, adept at managing teams and driving compliance. Proven track record in analytical method development and project management, enhancing operational efficiency. Skilled in regulatory inspections and mentoring, fostering growth while reducing defects in production processes. Proficient in HPLC and collaborative in fast-paced environments.
Overview
25
25
years of professional experience
Work History
Senior Specialist
Merck
04.2018 - Current
- Manage a team of quality personnel supporting B5 filing while ensuring personal development and growth for each individual.
- Oversee release of HPV at Elkton site; reviewing and approving: deviations, change control and protocols.
- Quality SME for HPV expansion projects, including impact and health assessments for the Elkton site.
- Accelerate Program-worked effectively in fast-paced environment to implement new software for quality across the Merck Manufacturing Network within nine months.
- Skilled at working independently and collaboratively in a team environment.
- Proven ability to learn quickly and adapt to new situations.
Senior Quality Specialist
Alcami
01.2007 - 04.2018
- Managed client and regulatory agency inspections; providing summary reports and appropriate responses to observations.
- Led quality review team from new product implementations through analysis and stability while maintaining compliance with industry standards.
- Developed and implemented quality control procedures, reducing defects in production processes.
- Mentored junior staff on best practices for quality assessment and process improvement techniques.
- Analyzed data from inspections to identify trends and recommend corrective actions to management.
Chemist
Erofins-AvTech Laboratories
09.2004 - 01.2007
- Developed and validated analytical methods to ensure high-quality results in research projects.
- Led the Methods and Validation team; managing timelines and client expectations
- Authored and approved validation protocols and reports
- Trained junior chemists, on HPLC development methods by facilitating knowledge transfer and enhancing team capabilities.
Quality and Compliance Specialist
AAI Pharma
06.2000 - 07.2004
- Analyzed compliance requirements to ensure adherence to regulatory standards.
- Developed and validated HPLC analytical methods.
- Participated in regulatory inspections.
- Conducted compliance reports and investigations to ensure adherence to quality standards
Education
MBA -
University of North Carolina At Wilmington
Wilmington, NC05-2018
Bachelor of Science - Biomedical Sciences
Western Michigan University
Kalamazoo, MI05-1995
Skills
- Quality Assurance Management
- Batch Disposition Subject Matter Expert
- Project Management and Leadership
- Regulatory Compliance and Inspections
- Analytical Method Development (HPL, GC, UPLC)
- Proficiently in SAP, Kneat, IPI, Veeva, Procal, LIMS, MES MEDs, Jira
Affiliations
- Quality Assurance Association
Timeline
Senior Specialist
Merck
04.2018 - Current
Senior Quality Specialist
Alcami
01.2007 - 04.2018
Chemist
Erofins-AvTech Laboratories
09.2004 - 01.2007
Quality and Compliance Specialist
AAI Pharma
06.2000 - 07.2004
MBA -
University of North Carolina At Wilmington
Bachelor of Science - Biomedical Sciences
Western Michigan University
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