Detail-oriented Quality Control Technician adept at reviewing materials and finished items for compliance with specifications and standards. Skilled in reporting and problem-solving with a history of making a positive impact on operations.
Overview
20
20
years of professional experience
Work History
Quality Control Specialist II
Creative Testing Solutions
04.2002 - 01.2022
Manages and participates in projects through CTS Project Maintenance Database involving all facets of laboratory work to include testing platforms, equipment, and staff management
Provides extensive training to laboratory personnel on Computer Maintenance Management System and building-wide Environmental Monitoring System
Writes, executes, and performs validation protocols to full implementation as well as implementing Standard Operating Procedures for Quality Control of equipment and related systems
Performs routine and infrequent (breakdown) preventative maintenance on equipment
Manages scheduled equipment maintenance and preventative activities in the laboratory
Provides prompt and courteous customer service for both internal and external clients
Coordinates service performed by equipment vendors (FSE's) for breakdowns, upgrades, and preventative maintenance as well as ensuring all manufacturer service documentation is accurate and complete
Documents QC/PM and validation activities, vendor maintenance, problems and subsequent investigation and resolution
Maintains equipment service records for quality control compliance
Investigates possibilities for potential equipment failure
Performs installation and validation protocol on new and repaired equipment
Conducts operational review and approval of laboratory Standard Operating Procedures in accordance with CTS, CFR, CLIA, FDA, and AABB standards
Works with Quality Assurance staff ensuring regulatory requirements are met, including corrective action, error management, and other required responses
Ensures regular review of all equipment and assay performance, maintenance, quality control and quality assurance records
Assists in maintenance of backup power systems, monitors and maintains environmental monitoring and central alarm system
Performs appropriate calibration and verification on ancillary equipment
Collaborates with appropriate departments to evaluate, implement, install and validate new test methodologies, laboratory equipment, and computer hardware and software
Receives proficiency samples, assigns and distributes samples to laboratory staff, and performs result entry within appropriate laboratory proficiency timelines
Allocates sufficient and appropriate space for fragile, temperature-controlled, and sensitive equipment supplies and documents
Maintains competency by participating in required training and continuing education programs
Leads and participates in Operational Excellence teams
Provided regular updates, via daily team Huddles, to team leadership on quality metrics by communicating consistency problems or production deficiencies
Initiated process improvements that led to reduced waste and increased production efficiency
Maintained several databases to track statistical data to further improve performance outcomes
Education
Bachelor of Science in Biology -
Grand Canyon University
Phoenix, Arizona
Skills
Six Sigma Yellow Belt Certification
SME Infor Computer Maintenance Management System
SME Plexxium Temperature Monitoring System
Excellent communication and presentation skills, written and oral
Detail oriented and sensitive to timelines
Exceptional aptitude for working with complex procedures and instrumentation
Proficient in computer applications such as Microsoft Excel, Word, Visio and lab-based software designed for testing