Derek Miller
West Jordan,United States
Summary
Accomplished Study Director with a proven track record at Nelson Labs, specializing in regulatory compliance and process validation. Expert in time management and training, I've led teams to success through meticulous attention to detail and effective mentorship. Renowned for enhancing customer service standards and scientific expertise, my career is marked by significant contributions to technical and scientific advancements.
Overview
16
16
years of professional experience
Work History
Study Director III
Nelson Labs
07.2021 - Current
- Subject matter expert on assigned standards and apply them appropriately to testing.
- Own section test method and equipment validations, including procedure development.
- Train and mentor Study Directors
- Address findings from internal and external/regulatory audits.
- Assist with CAPA assignments as needed.
- Serve as a technical and scientific expert with on-site sponsor visits.
Study Director II
Nelson Labs
07.2017 - 07.2021
- Ensure final report templates are compliant with procedures.
- Act as document owner for standard test procedures.
- Supervise and manage as assigned.
- Resolve quality events.
- Assist in hosting laboratory auditors and other visitors.
- Communicate with sponsors regarding a resolution of service and testing issues.
Study Director I
Nelson Labs
07.2012 - 07.2017
- Ensure reports are compliant with current procedures and they accurately reflect the data, results, and conclusions of the testing.
- Ensure accuracy of raw data.
- Ensure test controls and monitors are accurately recorded and reviewed.
- Collaborate within the quality event process.
- Ensure unforeseen circumstances or events are recorded and that corrective action is taken.
- Communicate regularly with sponsors as needed to relay study updates.
Lab Analyst II
Nelson Lab
01.2009 - 07.2012
- Performed testing, both GLP and non GLP; start to finish under supervision of the Study Director.
- Ensure testing is conducted according to approved procedures (SOP, CSS, STP, etc.)
- Know and follow applicable regulatory requirements (GMP, GLP, GCP, ISO, etc.)
Education
No Degree -
Salt Lake Community College
Salt Lake City, UTHigh School Diploma -
West Jordan High School
West Jordan06-1998
Skills
- Training and mentoring
- Customer service
- Dependability and time management
- Teamwork
- Leadership
- Adaptability
Timeline
Study Director III
Nelson Labs
07.2021 - Current
Study Director II
Nelson Labs
07.2017 - 07.2021
Study Director I
Nelson Labs
07.2012 - 07.2017
Lab Analyst II
Nelson Lab
01.2009 - 07.2012
No Degree -
Salt Lake Community College
High School Diploma -
West Jordan High School
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