GREGORY POTTS

QUALITY SYSTEMS/HEALTHCARE MANAGEMENT PROFESSIONAL

**** ******* **., ********, ** 90712 • 562-***-**** • adoshb@r.postjobfree.com AREAS OF EXPERTISE

HEALTHCARE & PHARMACEUTICAL PROCESS ENGINEERING PEOPLE & CROSS FUNCTIONAL Quality Assurance Management Oversight of Regulatory Compliance Team Building & Leadership FDA Reporting of Non-compliance & Product Recalls Project Controls & Project Management Coaching, Mentoring, Guiding Medical Intervention Services Trend Analysis & Reporting Troubleshooting and Resolution Patient Intake Coordination + Patient Education Financial Oversight and Budget Management Quick Thinking and Flexibility Medication Administration + Diagnostic Testing Failure Modes Effects Analysis (FMEA) Diplomatic and Solution-Oriented Problem (Deviations) Management Corrective and Preventative Action (CAPA) Organizational & Process Improvement Rehabilitation and Addiction Counseling Specialist Root Cause Analysis & Remediation Dedication to Patient Care With an extensive experience in highly regulated industries, spanning healthcare management, pharmaceutical and regulatory aspects of healthcare, blood banking, and rehabilitation, I have cultivated a career that spans many facets of healthcare. I started my career as a paramedic/EMT, and provided patient care for several years before transitioning into management roles for the American Red Cross. I am experienced in Quality Systems/Process Improvement at the management level, having led a department of 25 – 30 staff involved in the investigation of non-compliance, root-cause analyses, implementation and oversight of Corrective Action and Preventive Action (CAPA) plans, including Effectiveness Checks, and bring a wealth of expertise in designing and implementing quality systems and process management. PROFESSIONAL EXPERIENCE

ENGINEER, MECHANIC MCGUFF PHARMACEUTICALS INC 2020 – PRESENT

• Operation of pharmaceutical manufacturing equipment including automated aseptic fill lines, washers, ovens, and autoclaves

• Troubleshooting, Preventive Maintenance (PM), Corrective Maintenance (CM), Clean-in-place (CIP), and Steam-in-place (SIP) of pharmaceutical equipment; extensive facility maintenance and repair.

• Responsible for set-up, adjustments, sanitation, and operation of all machinery in the sterile filling area.

• Experience in using aseptic technique to conduct aseptic filtration and filling of finished product when needed

• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.

• Assess facility repairs, including clean rooms; review construction materials for adherence with cGMP and perform cost analysis for presentation to executive management.

• Assist Plant Engineers/Validation Engineers in equipment failure root cause analysis and resolution.

• Routine preventive maintenance on production manufacturing equipment to ensure continuous performance within their validated states OWNER, INTERVENTIONIST CARPE DIEM INTERVENTION SERVICES 2007 – 2020

• Oversee all business operations including, but not limited to, maintaining JACHO accreditation and HIPPA law compliance; growth and development of client base and rehabilitation centers.

• Maintain Continuing Education Units (CEU) Annual Compliance relating to addiction counseling to remain current on drugs being abused and new/novel treatment options.

• Maintain company financial responsibilities and budgetary adherence.

• Develop sub-contracts with national rehabilitation facilities.

• Organize and facilitate the entire intervention process with contracted families to ensure addict compliance.

• Coordinate all travel arrangements to ensure smooth transition during transport of clients to various rehabilitation facilities nationwide, including Mexico.

• Provide public speaking services and youth education on drug addiction for the prevention of drug use amongst children.

• Advocate for clients in court hearings and appearances.

• Work with the court to facilitate the bonding process; assume custody of released clients for transport to designated rehabilitation centers; initiate bond revocation when necessary.

MANAGER CHAMPION SIGNS 2006 – 2007

• Responsible for the daily activities of all staff; hiring, training, and evaluation of new employees.

• Evaluated and ensured the company was on track to meet monthly / yearly sales goals.

• Delivered performance assessment of the company against its business plans, and goals.

• Ensured productivity, and efficiency while reducing costs.

• Maintained quality control standards, and ensuring employees are meeting both production timelines, and milestones.

• Maintained, repaired, and performed preventive maintenance on production machinery.

• Supervised warehouse, plant design, and facilitated set-up for optimal production. MANAGER, PROBLEM MANAGEMENT AMERICAN RED CROSS, SOUTHERN CALIFORNIA REGION 2005 – 2006

• Managed 25 to 30 staff members within the Problem Management Department.

• Established strategic directions for departmental activities that were aligned with corporate, divisional (Western Division), and regional business / quality initiatives and ensured that such activities were in compliance with all regulatory requirements.

• Assisted in the development of the division Problem Management department budget to ensure appropriate and adequate resources in order to meet stated goals.

• Assessed regulatory and health risks associated with operational, procedural and process problems (deviations) in the collection of donor blood, manufacturing, labeling and testing of blood products for distribution into the public for patient consumption.

• Provided expertise, and served as the region’s primary point of contact and support by monitoring, reporting, and resolving problems violating regulated processes that occur in any phase of the American Red Cross (ARC) operations.

• Facilitated process improvements by coordinating activities of teams from various departments and regions for problem solving.

• Performed all duties and responsibilities in compliance with standard operating procedures, regulations outlined in the United States Code of Federal Regulations (CFR), and the Food and Drug Administration, state and local laws.

• Provided problem report summaries and trend analysis reports to National Biomedical Headquarters (BHQ).

• Responsible for correctly identifying all problems, performing accurate risk assessment, ensuring that appropriate immediate corrective actions were taken to ensure the safety, efficacy and quality of blood products,

• Lead investigation, root cause analysis and development and implementation of corrective and preventive action (CAPA) with other regions within the Southwest Division and Quality Assurance staff to formulate permanent solutions to problems.

• Finalized and documented all corrective action and preventive action plans and performed/monitored effectiveness checks to ensure that problems were appropriately addressed and did not recur. ASSISTANT DIRECTOR, COLLECTIONS AMERICAN RED CROSS, SOUTHERN CALIFORNIA REGION 2004 – 2005

• Managed all associated deviations/problems for the following departments: Automated Collections, Mobile Operations, Special Collections, Whole Blood Collections and Donor Record Department (DRD), within the Automated Problem Management System (APMS).

• Managed and supervised 8 staff members within the Collections Problem Management and Compliance Department which included scheduling of time, assignment of duties, auditing of receipts and expenditures, ensuring compliance within their job performance, ensuring process flow was consistent within the APMS system and restructuring as necessary.

• Participation in, formulation of and approval of all trend analysis and reports, Level 2/3 problem resolutions, Blood Product Deviations (BPD’s), FDA notifications, 483 observation responses as related to root cause analysis, corrective and preventive action plan formulation and effectiveness check analysis and standardization.

• Participated in FDA site inspections as needed to facilitate acquisition of requested information by the inspector and assisted in Questions and Answers (Q & A) during the inspection process.

• Monitored and completed monthly tracking and trending reports on all problems and trends and reported to the Collections Administration Department and BHQ on all on-going and newly identified trends per trend analysis.

• Participated in weekly / daily meetings such as Risk Assessments; QA Deviation, Regional Problem Management; Regional & Corporate Medical Review Board (MRB) advisory to brief stakeholders with the current status of problems/deviations. DEPARTMENT EDUCATION COORDINATOR AMERICAN RED CROSS, SOUTHERN CALIFORNIA REGION 2004 – 2005

• Trained incumbent and new hire staff on ARC procedures for manufacturing blood products within the production lab.

• Responsible for tracking the progress of training within the Manufacturing Department.

• Assisted the Training Dept. in the development, and writing of Local Operating Procedures, Training Implementation Plans, and Job Aides.

• Trainer for Blood Borne Pathogen, Safety, Dry Ice, Protecting the Product, and Defensive Driving courses to incumbents and new-hire staff.

• Responsible for the development of new training tools to assist the Training Dept., in the training and tracking of Production Lab, Q.C. Lab, and Biomedical Technicians.

• Assisted Production Lab Managers and Supervisors in the implementation of National Validation Plans.

• Assisted in the implementation of local Safety and Exposure Control Plans, ensuring the update of MSDS Binders, documentation and follow up of safety issues, and adherence to FDA and CalOSHA Regulations. ADDITIONAL EXPERIENCE

LAB TECHNICIAN AMERICAN RED CROSS, SOUTHERN CALIFORNIA REGION 2001 – 2002 MEDICAL STAFF PA LEISURE WORLD HEALTH CARE CENTER Seal Beach, CA 2000 – 2001 PARAMEDIC/ EMT LONG BEACH MEMORIAL MEDICAL CENTER, SOUTHERN CALIFORNIA REGION 1998 – 2000 PARAMEDIC/ EMT NAVAPACHE REGIONAL MEDICAL CENTER 1996 – 1998 BACK OFFICE PHYSICIAN’S ASSISTANT WHITE MOUNTAIN FAMILY PRACTICE 1996 – 1998 BACK OFFICE PHYSICIAN’S ASSISTANT BLUE RIDGE REGIONAL MEDICAL CLINIC 1996 – 1998 ASSISTANT PROJECT MANAGER MAGNUM CONSTRUCTION ENTERPRISES 1994 – 1996 EDUCATION

BACHELOR OF SCIENCE, CONSTRUCTION ENGINEERING CALIFORNIA STATE UNIVERSITY, LONG BEACH Long Beach, CA 1994 Minor: Project Management

ASSOCIATES, GENERAL EDUCATION LONG BEACH COMMUNITY COLLEGE Long Beach, CA

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