Operations, Management, QA, Training
Resume:
CHRISTIAN ZERO
Texas City, Texas *****
**************@*****.***
PROFESSIONAL SUMMARY
Experienced tissue banking and biologics operations leader with 20+ years of progressive responsibility in processing, compliance, engineering support, operational efficiency, and quality-driven production. Extensive background in human tissue processing, cleanroom operations, process validation, deviation/complaint investigations, GMP/cGTP compliance, and cross-functional coordination. Recognized for improving processes, strengthening compliance, leading investigations, developing training programs, and enabling efficient tech transfers and new product introductions. Deep expertise across diverse tissue types, sterilization methods, and regulatory standards.
PROFESSIONAL EXPERIENCE
Alamo Biologics — San Antonio, TX
Operational Efficiency Advisor May 2023 – February 2026
Reviewed, analyzed, and optimized departmental procedures and resources to improve operational efficiency.
Implemented policies and procedures that enhanced daily workflow and regulatory compliance.
Coordinated equipment and process validations supporting operations and product development.
Developed, reviewed, and approved employee training programs; provided on-the-job training as needed.
Performed internal audits of tissue operations and supported the closing and resolution of deviations and customer complaints.
Lead investigative activities and coordinate corrective actions across departments.
Supported technical transfer activities, collaborating with Processing, Quality, and Product Development to streamline process implementation and new product startup.
Engineering Associate Nov 2023 – May 2024
Revised SOPs to align with current Good Manufacturing Practices (cGMPs).
Created product specifications and introduced new equipment to improve processing efficiency.
Maintained and supported processing equipment performance.
Led transfer of new products from development into cleanroom processing operations.
Developed and facilitated operator and technician training programs.
Executed qualification, verification, and validation activities.
Ensured manufacturing processes met performance targets, maximizing productivity and minimizing donor yield loss.
Provided aseptic processing expertise involving bone, tendon, ligament, cartilage, skin, and birth tissue.
MTF Biologics — Jessup, PA
Processing Technician Oct 1999 – Jan 2003
Operated production equipment per cGMPs and SOPs; calibrated and adjusted tools including calipers, micrometers, and gauges.
Monitored processing operations for quality and productivity, maintaining logs and documentation.
Performed equipment startup/shutdown, cleaning, and decontamination.
Operated and maintained autoclaves and sterilization systems.
Packaged finished products and trained new technicians.
Processing Supervisor Jan 2003 – Jan 2008
Directed and coordinated production staff across multiple tissue processing functions.
Planned schedules, assignments, and production sequences to meet output goals.
Ensured compliance with safety, sanitation, and quality standards.
Analyzed work orders and production data to optimize operational performance.
Prepared production reports maintained cost and yield records and executed personnel actions including hiring and evaluations.
Established production goals, labor requirements, and standards.
Processing Training Coordinator / Complaint Management Specialist Jan 2008 – Jan 2016
Coordinated training for new and existing processing personnel; maintained training documentation.
Created and maintained SOPs, work instructions, and finished goods specifications.
Conducted cleanroom and equipment validations.
Performed complaint investigations, discrepancies, and nonconformances.
Collaborated with sales, engineering, and surgeons to resolve complaint-related issues.
Led staff retraining and conducted monthly quality inspections of finished tissues.
Served as liaison between Client Quality, Sales, and Processing.
Processing Compliance Coordinator Jan 2016 – 2023
Supported internal operations across all value streams to ensure compliance, consistency, and accurate tissue disposition.
Identified improvement opportunities impacting compliance, yield, and standardization.
Collaborated with Operations, Engineering, and Training on best practices, personnel development, and process enhancement.
Developed training programs and ensured consistent application of standards across all tissue forms.
Additional Experience
Kingston Fire Department — Kingston, PA
Firefighter EMT-P Jan 1989 – Jan 1993
Turker Hill (Division of Kroeger) — Plains, PA
Area Supervisor Jan 1987 – Jan 1993
Progressed from Assistant Manager to Area Manager overseeing 14+ stores within a 60+-square-mile region.
Circuit City — Wilkes-Barre, PA
Sales Counselor / New Store Setup Specialist Jan 1993 – Jan 1999
Led specialty electronics room setups and coached new sales teams during store openings.
Completed Manager Mentor Program in 1998.
EDUCATION
Luzerne County Community College — Nanticoke, PA
Associate degree, Commercial Art (1989)
Associate degree, Painting & Illustration (1991)
Degree of Specialization, Fine Art (1991)
Certificate EMT-P (1992)
Coursework Toward associate degree, Registered Nursing (Completed all but final clinical rotation) (1996)
Associate degree, Surgical Technology — Orthopedics & General Surgery focus (1999)
Wyoming Valley West High School — Plymouth, PA
High School Diploma, 1987
CERTIFICATIONS & TECHNICAL SKILLS
Regulatory & Compliance
cGMP (21 CFR 210/211)
Quality System Regulation — QSR (21 CFR 820)
cGTP (21 CFR 1271)
TGA biologics compliance
ISO 9001 / 13485 Standards and Compliance
Technical Expertise
Aseptic tissue processing (bone, tendon, ligament, cartilage, skin, birth tissue)
Cleanroom operations, validation and certification
Sterilization methods: Steam, Gamma, Chemical, VHP, Ethylene Oxide
CNC operation & programming
Measuring instrumentation (calipers, micrometers, vision systems)
Quality & Systems
Master Control (Power User)
Compliance Wire (Power User)
Pilgrim QMS — CAPA/NC/Complaints
Microsoft Office (Word, PowerPoint, Excel, Visio, Publisher)
Biomaterial Tracking & Management System (BTM)
Ideagen Quality Management
Process Improvement
Lean Manufacturing (Kaizen, 5S, Kanban, Standard Work, Capacity Analysis)
Six Sigma
Scrum Project Management
Technical drawing and blueprint interpretation
Industry Credentials
Certified Tissue Bank Specialist (CTBS) 2010 through 2022
National Tissue Processing Instructor for CTBS Certification 2010 through 2022
Creator of the concept and prototype for MTF’s top-selling cervical graft (CC-ACF)
Creator of Alamo Biologics second generation DBM Putty
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