Dave Astill
Stansbury,Ut
Summary
Project Manager versed in all aspects of project and personnel management. Results-oriented and high-energy professional with talent for leading by example and inspiring peak performance. Dedicated to fostering strong effective team relationships.
Technical/Analytical
• Authored, Reviewed, Approved ANSI/ISO 11135/13485 related sterilization protocols and Sterilization/Medical Device build diagrams
• Installed sterilization equipment, ancillary devices, racking, walls and computer drives/programs (FIT & FAT testing)
• Tested, calibrated, checked daily/weekly/monthly/semi-annual/annual preventative maintenance
• Identified (troubleshot) and corrected items not meeting FDA/OSHA/EPA along with ANSI/AAMI specifications
• Assessed and Certified installation, operational and performance qualification (IQ, OQ, PQ) documents
• Operated hand tools, power tools, welders and different types of machinery/lifts
• Proficient in Microsoft Excel, Word, PowerPoint, Outlook and Custom Employer Databases (Oracle)
Leadership
• Maintained studies through various departments while including sponsors (Customers)
• Carried out employee training, discipline as well as highlighted behavior
• Supervised sterilization warehouse (21 employees) and ensured assignments were completed safely and efficiently
• Designated positions and assignments to co-workers/employees
• Integrated “One Company” Values through local and corporate locations
• Managed and coordinated employees/services for a part-time business
Communication
• Efficiently planned critical timeframes to meet/exceed customer requests
• Created and conducted PowerPoint presentations on safety procedures and performance reviews
• Corresponded with internal and external customers, from Laboratory assistance to engineers and FDA regulators
• Scheduled Routine runs, Validation processes, equipment downtime, information hand offs and IQ/OQ tasks
Organization
• Developed customer information to assist the progression of products
• Applied “white board” thoughts in everyday applications
• Prepared and maintained daily tasks, data, records for quick and accurate information
• Incorporated 5S (Sort, Set, Shine, Standardize, Sustain) into production and office areas
• Produced and implemented work/task flow for internal departments
Financially
• Assembled / Authorized Expenditure Authorizations of ≤ $25,000
• Continually increased customer study revenue by ≥ 2% since 2012
• Corrected and Submitted employee timecards for accurate payroll
• Oversaw “EOSTAT” (Expedited) processing requests and billing > $1,000,000 annually
Overview
17
17
years of professional experience
Work History
Quality Assurance Technician
Kelly Services providing work for Coherex Medical
Salt Lake City, UT
07.2023 - Current
- Performed detailed inspections of products to ensure compliance with quality standards.
- Developed and implemented inspection procedures for incoming materials.
- Analyzed data from test results and identified areas needing improvement.
- Conducted root cause analysis on defective parts and provided corrective action recommendations to management.
- Maintained records of all quality control activities, such as tests and inspections performed.
- Created reports summarizing quality assurance activities for upper management review.
- Tracked non-conforming material using appropriate documentation systems.
- Recommended changes in procedures or specifications when necessary.
- Implemented best practices for ensuring high levels of product quality.
- Collaborated with cross-functional teams to develop strategies for improving product reliability.
- Participated in regular meetings with suppliers to discuss quality concerns and improvements.
- Supported internal audits by verifying accuracy of documents against actual conditions.
- Collected, analyzed and summarized data including failed processes and recalls to create accurate quality documentation.
- Conducted tests to validate compatibility with programs, hardware and operating systems.
Special Event Coordinator / Maintenance Specialists
University of Utah - Commuter Services
Salt Lake City, UT
07.2022 - 06.2023
- Collaborated with clients to identify their goals and expectations for the event.
- Ensured effective communication between vendors and suppliers before, during and after the event.
- Organized vendor contracts, negotiated fees, and ensured compliance with all regulations.
- Coordinated with internal teams to ensure timely delivery of services for events.
- Managed logistics related to transportation, catering, signage for events.
- Facilitated, trained and performed operational, logistic, quality and human resource duties.
- Issued employee remedial actions and consequences.
Technical Advisor - (SEAS) Sterigenics Expert Advising Services
Sterigenics (A Sotera Health Company)
Salt Lake City, UT
01.2020 - 01.2022
- Oversaw, led, and orchestrated test plans and actions at ten facilities in North and South America
- Generated quotes for the inside and sister company sales team's
- Material build timelines from sponsors
- Prioritized and organized tasks to efficiently accomplish service goals.
- Comprehension of protocol requirements and milestones
- Assimilated NO2 sterilization modality by working with the FDA and creating validation tactics
- Logistics of test samples, production units or dunnage/ballast material for processing
- Created sterilization programming to follow EPA regulations and reduce the amount of EO consumed
- Formulated, deciphered testing and all associated processing data
Operations Supervisor
Sterigenics (A Sotera Health Company)
Salt Lake City, UT
12.2018 - 01.2020
- Facilitated, trained and performed operational, logistic, quality and human resource duties
- Issued employee remedial actions and consequences
- Filled in for upper management rolls for dealings with facility concerns
- Drove a smooth process from receipt through shipment and billing
- Interviewed, hired, and on boarded employees
Validation Coordinator
Sterigenics (A Sotera Health Company)
Salt Lake City, UT
03.2011 - 11.2019
- Learned and helped develop New Sterilization Technology for company (NO2 sterilization)
- Write / Review / Execute EO Sterilization Protocols
- Ensure FDA / GMP / ISO regulations are being followed
- Interface with Sponsors / Laboratory Personnel and fellow departments through verbal and written communication
- Report to upper management with statuses and progress reports
- Effectively planned and directed sponsor studies
- Traveled to other facilities around the world to train Company Policy and Procedure
- Meticulously monitored customers processing / invoicing activities
Janitorial Services
SLC Sea-Monkeys (Owner/Operator)
Salt Lake City, UT
08.2016 - 07.2019
- Tracked employee schedules and time worked
- Compiled expenses, budgets, and payroll
- Stocked and ordered supplies
- Executed required tasks and requests
Quality Assurance Technician
Sterigenics
Salt Lake City, UT
06.2009 - 03.2011
- Performed Empty Chamber / Aeration temperature and RH Profiles
- Assigned, filed, and tracked continual training documents
- Conducted employee exposure tests and monitoring plans
- Developed Lean practices
- Created, Reviewed, and placed into practice company Standard Operating Procedures
- Participated in Government / Sponsor Audits of sterilization facility
Lead / Assistant Operator
Sterigenics
Salt Lake City, UT
10.2006 - 06.2009
- Instructed / Directed operator duties
- Understood and carried out written and verbal instructions
- Completed 10-hour OSHA training course
- Adapted and reacted to equipment performance and customer requests
Education
<ul><li>Developed customer information to assist the progression of products</li><li>Applied “white board” thoughts in everyday applications</li><li>Prepared and maintained daily tasks, data, records for quick and accurate information</li><li>Incorporated 5S (Sort, Set, Shine, Standardize, Sustain) into production and office areas</li><li>Produced and implemented work/task flow for internal departments</li></ul>
Skills
- Leadership- ability to work with different personal styles and approaches, collaborate, problem solve and communicate the plan forward
- Project Management- unafraid of jumping in and understanding a task, aligning targets/goals and motivating progress
- Attention to detail- meticulous in quality, cognizant of trends, capable of spotting issues before they snowball
- Test Methodology Design
- Quality Report Preparation
- Audit Compliance
- Documentation And Reporting
Affiliations
- Outdoor enthusiast, any and all sports related to the unique Utah seasons.
- Scuba certified
- Mechanically inclined
References
References available upon request.
Timeline
Quality Assurance Technician
Kelly Services providing work for Coherex Medical
07.2023 - Current
Special Event Coordinator / Maintenance Specialists
University of Utah - Commuter Services
07.2022 - 06.2023
Technical Advisor - (SEAS) Sterigenics Expert Advising Services
Sterigenics (A Sotera Health Company)
01.2020 - 01.2022
Operations Supervisor
Sterigenics (A Sotera Health Company)
12.2018 - 01.2020
Janitorial Services
SLC Sea-Monkeys (Owner/Operator)
08.2016 - 07.2019
Validation Coordinator
Sterigenics (A Sotera Health Company)
03.2011 - 11.2019
Quality Assurance Technician
Sterigenics
06.2009 - 03.2011
Lead / Assistant Operator
Sterigenics
10.2006 - 06.2009
<ul><li>Developed customer information to assist the progression of products</li><li>Applied “white board” thoughts in everyday applications</li><li>Prepared and maintained daily tasks, data, records for quick and accurate information</li><li>Incorporated 5S (Sort, Set, Shine, Standardize, Sustain) into production and office areas</li><li>Produced and implemented work/task flow for internal departments</li></ul>
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