Colby Tate Email & Phone Number

San Antonio, Texas Metropolitan Area

Responsible for management of the Quality Systems Assessment group, including leading weekly meetings, coordinating, and leading audit assessments, communicating audit/surveillance schedules with divisions and cost centers, and sending weekly updates to IQS management of group tasks. Additionally, Mr. Tate continues to perform internal audit and surveillance programs to various national and international standards including ISO 9001, ISO 17025, ISO 14001, ISO 13485, and GLP/GMP programs. As a Quality Control and Quality Assurance (QC/QA) professional, his experience ranges from testing pharmaceutical raw materials and active ingredients to developing and implementing global Quality Systems.

San Antonio, Texas Metropolitan Area

San Antonio, Texas, United States

San Antonio, Texas Area

Responsible for establishing a corporate Quality (QA/QC) system and team that promotes customer satisfaction and that positively impacts the financial performance. Champion continuous improvement efforts and defect reduction initiatives to establish an effective Quality Management System (QMS).• Developed three year Strategic Quality Plan for global quality program.• Revised Incoming Quality Inspection process and system to increase throughput and accuracy of measurements.• Implemented Line Inspection training program for WIP and finished goods inspections.• Established Supplier Surveillance Program including supplier risk ranking, scorecard system, and supplier site audits. • Manage the CAPA and continuous improvement program for San Antonio operations.

Responsible for planning, coordinating, and executing auditing/assurance activities, inclusive of audit reporting and corrective action plan monitoring at locations globally. Specific responsibilities include assessing adherence to management processes, standards and work methods that are designed to mitigate risks to achieving the organization's service quality objectives, such as Design and Development Planning, Project Managing Change, Job Execution Requirements and Performance Assurance. Responsible for comparing and evaluating possible courses of conduct and action for each audit and determining and executing the audit activity. Responsible for supervising less senior positions during the audit process. Position requires experience in field operations or support and expertise in management processes. Requires 50%-75% travel, both domestically and internationally.

Houston, Texas Area

The Global QA/QC Laboratory Manager is accountable for the training and implementation of Quality Assurance and Quality Control Program for Baroid as well as supervises the Quality Assurance and vendor surveillance program to ensure quality requirements of vendor provisions are met. The Global QA/QC Laboratory Manager is expected to support quality operations concerns in the 0-3 month time frame. The remaining focus should be on forward looking activities in anticipation of future quality issues; specifically looking 3-18 months into the future.In charge of a global workforce and budgets of $10MM

San Antonio, Texas Area

• Responsible for the timely delivery of project design documentation for 4, $1-3M projects concurrently• Facilitated the approval of project deliverables to include, gathering engineering requirements, and monitoring their subsequent outputs for compliance through a series of cross functional and international team meetings. • Facilitated, documented, and distributed meeting minutes for all team meetings.• Authored, tracked, and archived the Design History File (DHF) for 3, $1-3M projects in parallel while maintaining the DHF as appropriate throughout product life cycle.

San Antonio, Texas Area

• Responsible for the Quality Control Department including the evaluation of Quality Control results and the decision to release products. Ensures that the quality system is established and maintained efficiently, reports the quality system performance to management for review, and promotes awareness of regulatory and customer requirements throughout the organization;• Hired, coached, and developd employees to continually improve their skills through implementation of training and competencies program within the Quality Control Department• Lead implementation of internal and external quality activities• Execute process improvements as they relate to quality system compliance with ISO/GMP requirements.• Managed and directed offsite R&D contractor in an effort to launch forward model programs.• Successfully submitted NDA for new product developed in offsite R&D facility• Lead implementation of corrective actions related to product/process issues• Lead 6 sigma lean project within Boerne facility and decreased rework error by 10% and manufacturer time by 1 day.• Manage supplier quality issues • Compile data and present for Upper Management• Drive Corrective Action Preventative Action (CAPA) resolution• Daily, weekly and monthly monitoring of customer complaint data and resolutions• Continuous improvement of the QMS, ISO, and GMP systems• Implemented Change Order process for manufacturing and supply chain• Root Cause Counter Measures (RCCM) action plans• Active ownership and leadership of CAPA’s related to product/process improvements• Performed IQ/OQ/PQ validation for laboratory and manufacturing equipment.

San Antonio, Texas Area

• Established project milestones, managed project timelines, and ensure that the resources assigned to projects were adequate to meet project objectives for projects in the $1MM-2MM range. • Established and maintained functionally integrated project schedules to enable accurate project, financial and portfolio analyses and ensured accurate inputs were provided into business planning processes; Ensured alignment with project sub-teams and functional partners.• Monitored project deliverables against plan and work with project teams and management to identify risks, contingencies and alternatives to keeping deliverables and overall project on schedule• Utilized systems and processes necessary for project team planning, tracking, and execution of projects• Facilitated team meetings effectively; provide meeting objectives and agendas in advance. Coordinated the compilation of well-structured periodic progress reports and prepare clear, detailed minutes of all project meetings, for customer and management reviews.• Conducted routine program management reviews with Project Teams and Sr. Management. Keep senior management informed of project concerns/issues/successes.

San Antonio, Texas Area

• Ensured drug and medical device products produced were manufactured, packaged and released to meet safety and regulatory requirements for customer and consumer use• Motivated and developed a group of thirty people over 3 shifts and two locations to function as a team• Supervised employees who inspected products on-line ensuring the Acceptable Quality Limit was within established specification• Provided training to employees for new and revised processes and procedures• Created Test Standards and Methods of Analysis for newly launched products• Revised and implemented Standard Method of Analysis• Reviewed and approved Packaging Modules and Implementation Tracers• Reviewed and approved Fill Trial/Packaging Validation and Protocols• Revised the QA Line Inspector’s Training and competencies Manual• Worked on a cross-functional team to revise SPC for aerosol manufacturing, packaging and on-line inspection process• Set-up user profiles and tables with the SPC Software as Software Administrator• Assisted in conducting internal laboratory (Quality Control and Research and Development) audits• Participated in answering questions pertaining to Line Inspection during internal, customer, and regulatory audits• Worked specifically with explosion-resistant manufacturing, and packaging products into blisters, bottles, pouches, tubes, jars, and syringes

• Served as primary Quality contact for top three pharmaceutical customers in a contract development and manufacturing organization. • Ensured proper documentation of manufacturing batch records, and material and product specifications were being followed • Executed, reviewed and approved manufacturing deviations, investigations, annual product reviews, consumer complaints, technical reports, change controls, manufacturing batch records, and material and product specifications. • Served as consultant to Operations staff to ensure appropriate documentation, compliance to SOPs, and consistency with regulatory requirements. • Represented Quality department in internal and external audits. • Ensured completion of appropriate CAPA to maintain product quality and robust internal systems and processes. • Developed and executed formal training for QA personnel.

-Responsible for performing the testing of chemical components, including chemical testing on packaging components-Performs wet chemistry testing on chemicals-Performs analysis on various instruments (HPLC, GC, UV/VIS)-Performs processing in Empower-Responsible for evaluating data and perform troubleshooting, exhibiting problem-solving skills-Demonstrate the ability to multitask and troubleshoot-Perform tasks involving the final review of data, assists in conducting investigations, reviews and updates SOP’s and SMA’s, including technical review and method interpretation.

Chemistry Faculty member in charge of Chemistry for Agriculture Majors and Chemistry for Nursing Majors as well as General Chemistry for Science Majors. Three hour credit lecture course as well as one hour laboratory course.

Undergraduate Research into Boron Neutron Capture Therapy, Organic synthesis.