Kirk Story
- Role
- Technical Operations Principal Engineer at Quva
- Location
- Phoenixville, PA, US
- LinkedIn followers
- 500 followers
About Kirk Story
Proven pharmaceutical industry professional with extensive experience managing and…
Experience
Technical Operations Principal Engineer
Jan 2017 — Present
Provide technical support for a 503B compounding pharmacy operation with a predominant focus on the production of sterile injectable products. Lead potency investigations. Conduct risk assessments. • Led potency investigations, identifying opportunities for enhancement in operating procedures, process design, raw materials usage and laboratory analysis with resultant 50% decrease in failure rate from 2017 through 2018. Conducted weekly report-outs to senior leadership on status of open investigations, relevant trends and recommended actions. • Led risk assessments for topics including antibiotic/hormone compounding, facility reclamation and the co-location of sterile and non-sterile operations, supporting uninterrupted operations for existing processes while also identifying items for remediation, areas for enhancement and opportunities to eliminate non-value-added work. • Completed manufacturing batch record modernization and re-design, instituting standard work, enhancing document quality and reducing human error. • Above actions supported company’s goals of expanded capacity and geographic reach with multi-x increase in doses sold from 2017 through 2018.
Skills
- Regulatory Requirements
- Regulatory Documentation
- Aseptic Processing
- Manufacturing
- Sterilization
- Biopharmaceuticals
- 21 Cfr Part 11
- Pharmaceutical Industry
- Vaccines
- Regulatory Affairs
- Technology Transfer
- Quality System
- Project Planning
- Utilities
- Clean Rooms
- Equipment Qualification
- Capa
- V&V
- Sop
- Management
- Continuous Improvement
- Biologics
- Regulatory Compliance
- Project Management
- Change Control
- Biotechnology
- Qualification Testing
- Process Validation
- Quality Assurance
- Cleaning Validation
- Gmp
- Validation
- Biopharmaceutics
- Document Review
- Documentation
- Fda
- Regulatory Submissions
- Pharmaceutics
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