Charles A. Van Nort

**** ******** ****** • North Charleston, SC 29405 • H&C: 843-***-**** • ad3ln7@r.postjobfree.com

Professional Profile

I am a dedicated professional with over 35 years of management/director experience, and 26 years Military service. I offer a broad experience in facilities, quality and operational management that saved over $3,000,000 and oversaw a $765,000,000 Capital Development Project (SCIP). I am highly focused in supporting complex and deadline driven operations with excellent organizational and time management skills with a proven ability to independently multitask plan and direct demanding operations and complex schedules. Financed, designed and oversaw $1M annual food and beverage start up as my last project.

Core Competencies

Organizational Leadership • Facilities Management • Operations Management • Validation, Operations, Regulatory & Quality Compliance • Program Management • Quality Oversight • Staff Management • Budget Management • Project Management • problem resolution • Facility Quality Plan Development • Contracting & Procedure Development • Staff Training • Relationship Building

Professional Experience

Italian Gourmet Market & Deli North Charleston, SC 2/2017- 8/2023

Operating business owner

Designed and developed a new start up Italian restaurant & market mixed concept as principal owner, operator and manager.

Managed working staff of 12 people/$1M gross annual

Marketed for Sale or Lease and relocation August 2023

Configured POS (Clover) for retail/restaurant

Ran day to day operations/customer relations

American Red Cross: National Biomedical Headquarters, Ashburn, VA 7/1995 - 8/2016

Facility Manager 8/2011 - 9/2016

Oversaw a multi-staging support facility that included IT testing and development, Disaster Recovery and Deployment and Senior Contract for facility management. Supported daily activities to over 200 staff. Provided Quality Oversight and developed contracts. Directed Logistical Personnel, provided R2 on-site IT support for Medical Device Submission and approve all 510K.

Successfully introduced Auditing into NHQ Vendor oversight that led to multiple oversights and unnecessary contract operations and maintenance with a projected savings of over $800,000 over a five year period and actual Net in access of $500,000 while increasing overall oversight with specific scope of works and requirements.

Director Validation, Operations, Regulatory and Quality Compliance 1995 - 2011

Directed a highly regulated and quality technical management and validation team in operations, quality and regulatory activities. Oversaw vendor qualification, equipment purchasing, project, protocol and procedure development, qualification activities, validation, facility systems, commissioning, training and workshops. Established core metrics for seven Divisional Directors, 36 regional report facility managers and 26 national management development sector staff for a multi-billion dollar biomedical division of the ARC.

Accounted for over $3 million in cost reduction and contract reviews

Handled registration and licensure submissions (BLAs) to the Food and Drug Administration (FDA). Reviewed submission to ensure all FDA CFR requirements for Clinical Biologics License Applications (BLA’s) are met. Oversaw and reviewed 510K submissions, investigational new drug applications (IND) and drug registration labeling. Managed 2830’s (FDA Blood and Tissue Facility Registrations), 3356’s (Tissue Registration) and 356h (New Drug Applications). Reviewed 510K submissions for biomedical software and INDs for our Diagnostic Manufacturing Division. Collaborated with the FDA, AABB, CLIA and State/local inspectional agencies on Adverse Determination Letters (ADLs), 483 responses, 482 ongoing inspections and FDA-2830 Registrations. Participated with the National scope Material Review Boards (MRBs)

Managed Call Tracking System (CTS), performed Project Management and Departmental and System Oversight. Developed and implemented a national Facility Quality Plan to manage and ensure all regulated functional areas are provided with quality oversight and documented to support the activities. Reviewed Quality Assurance System and oversaw Quality Audits Management. Oversaw Strategic Corporate Investment Program (SCIP), a $765M infrastructure improvement program. Consolidated and streamlined core manufacturing and oversaw Commission and Qualify remodeled and newly constructed facilities. Incorporated process validation master plan.

Charles A. Van Nort

Resume – Page Two • H&C: 843-***-**** • ad3ln7@r.postjobfree.com

Professional Synopsis (continued)

Technical Services Director

Managed commissioning, decommissioning, validation and qualification of three multi-million dollar blood processing facilities in Pomona, CA worth $54, Johnstown, PA worth $42M and Douglasville, GA worth $48M. Served as Training Coordinator for standardized temperature mapping approach. Planned, managed and ensured adherence to a $5M budget. Recruited staff/contractors, mentored and developed management core and oversaw professional development and training curriculum. Standardized facility equipment/supply and informed business core project owner for roll out projects such as a National Validation Master Plan and Calibration Program. Developed National workshops for standardized training approach.

Developed and implemented facility specific new/renovated facility VMPs for over 30 Capitol projects.

Established a national core temperature mapping system for over 15,000 environmental controlled units.

Director of Validation & Calibration Department

Established a system wide calibration program for 47 facilities and developed standardized calibration techniques.

Reduced calibration vendors by 82% with an annual cost savings of over $800k.

Contributed to team effort by accomplishing related results as needed.

Supported over 300,000 equipment protocols and maintenance documents. Managed a $5.2M annual departmental operating budget.

Radiation Safety Officer 1998 - 2009

Commissioned new radiological source equipment and decommissioned outdated radiological source equipment. Performed Qualification/Validation, Dose Mapping and Contracting.

Demonstrated initiative and ability to be productive without supervision.

Set all facilities on one national standard incorporating all regulatory requirements that reduced licensing costs by over $350,000 annually.

Production Laboratory Operations Manager 1995 - 1999

Established written procedures involved in compliance with FDA regulations. Reviewed and revised regional SOP’s and evaluated performance of procedures in the work environment. Negotiated union contracts and grievances and conducted employee performance appraisals. Coordinated vacations, oversaw daily operations, scheduled staff and supervise and trained 35 laboratory personnel and three line supervisors.

Dealt with 5 unions, Teamsters and SEIU, that helped take back control of our facility personnel and streamlined negotiations for much needed operations while cutting overtime by 80% saving the company $600,000 annually in unnecessary OT shifts by streamlining production without reducing staff, while increasing our production by 30%.

Other Relevant Experiences

United States Army Reserve 1983 - 2004

2290th United States Army Hospital, Walter Reed Laboratory NCOIC 1998 - 2004

U.S. Army University Faculty ROTC Instructor:Northeastern University & Boston College 1994-1998

Corning-Metpath Inc., Boston, MA 1992 - 1995

Processing Operations Manager

US Army: Dessert Storm Saudi Arabia 9/90 – 7/91

Coldwell Banker Defelice, Providence, RI 1986 - 1989

Real Estate Broker

Education

BS/BA, 1997–1999: Eastern Nazarene College Business Administration

ASSC MT, 1991-1992: Middlesex College Medical Technologist

SMU MLT Sponsored Program, ASSC MLT, 1983–1984: Academy of Health Sciences

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