Quality Control Regulatory Compliance

KHARLO BAYLOSIS CORTEZ

*********@*****.***, Cel: 757-***-****

OBJECTIVE

To leverage my exceptional multitasking skills, strong work ethic, and commitment to efficiency in a challenging environment. Eager to contribute to team success by balancing multiple responsibilities, prioritizing tasks effectively, and maintaining a high level of productivity. Seeking a position that will allow me to continue growing as a diligent and reliable professional who consistently meets or exceeds expectations. As a Tissue Banking Supervisor, I oversee and coordinate daily tissue processing operations with an emphasis on technical excellence, regulatory compliance, and safety. I excel at building trust with a team through outstanding service and communication. Skilled in accurate documentation, data tracking, and workflow efficiency via strong computer proficiency. A self motivated leader, I foster teamwork, solve problems, and guide teams to meet performance goals. I aim to apply my experience in a role that values and benefits from my leadership and operational skills.

EDUCATION

Old Dominion University

Bachelor’s of Fine Arts (BFA): Concentration in Graphic Design with a Minor in Art History. Norfolk, VA

Tidewater Community College

Associate’s Degree in Applied Science

Virginia Beach, VA

EXPERIENCE

LIFENET HEALTH ORG.

Virginia Beach, VA 2013-2025

Supervisor, Production - Musculoskeletal

(2024-2025), 2nd Shift

● Review daily tissue processing operations, including wet/dry processing, disinfection, clean room work, trimming, debriding, and packaging.

● Ensure compliance with regulatory requirements (FDA 21 CFR 1271, cGMP/cGTP, AATB,

(OSHA).

● Maintain and enforce good documentation practices (batch records, SOPs, logs, environmental monitoring)

● Train, mentor, and evaluate staff; oversee hiring, performance reviews, and cross training.

● Manage quality control, non conformances, deviations, corrective/preventive actions (CAPA), and product yields.

● Coordinate with quality assurance, supply chain, engineering etc., to meet production schedules and maintain standards.

● Monitor safety, hygiene, aseptic technique, clean room protocol, and make sure safety regulations are followed.

● Perform administrative tasks: schedule staff, maintain records, generate reports, release donors, recommend process improvements.

Master Musculoskeletal Technician

(2023-2024), 2nd Shift

● Perform complex tissue processing tasks: dissection, trimming, cutting, cleaning, disinfection, cryopreservation, lyophilization, packaging — for a variety of tissue types under strict SOPs.

● Ensure compliance with regulatory and quality standards (FDA, AATB, cGTP/cGMP, etc.), including cleanroom and aseptic processing protocols.

● Maintain documentation: batch records, work instructions, environmental monitoring logs, equipment calibration, and ensure traceability of all tissue products.

● Lead and deliver training programs: develop training materials, conduct classroom & hands on training for new hires and existing staff on technical procedures, safety, and quality practices.

● Evaluate trainee competency: observe performance, give feedback, test or certify staff in critical tasks, retrain as needed.

● Monitor and maintain equipment, supplies, and workflow: ensure tools are calibrated, supplies stocked, processing areas audit ready.

● Mentor new/seasoned technicians: provide guidance on procedure execution, process improvements, best practices, safety.

Senior Musculoskeletal Technician

(2022-2023), 2nd Shift

● Participating, planning, and leading team-oriented tasks.

● Ensuring compliance with regulations (FDA, AATB, cGTP / cGMP), aseptic techniques, environment / clean room protocols, and maintaining quality control at all stages.

● Managing documentation: accurate batch records, work instructions, environmental monitoring, equipment calibration, traceability of tissue products.

● Troubleshooting process issues: identifying, analyzing, and resolving yield problems, defects or nonconformances; recommending or implementing corrective/preventive actions.

● Supporting continuous improvement: process optimization, participating in audits or validations, helping update SOPs or protocols.

● Leading by example: ensuring safety, accuracy, reliability, and fostering a culture of quality and accountability among team members. Supervisor, Production - Musculoskeletal

(2021-2022), 1st Shift

● Perform administrative tasks: schedule staff, maintain records, generate reports, recommend process improvements.

● Monitor safety, hygiene, aseptic technique, clean room protocol, and make sure safety regulations are followed.

● Manage quality control, non conformances, deviations, corrective/preventive actions (CAPA), and product yields.

● Maintain and enforce good documentation practices (batch records, SOPs, logs, environmental monitoring).

Musculoskeletal Production Trainer/Subject Matter Expert for Sports Medicine

(2015-2021), 1st Shift

● Providing instruction for trainees regarding allograft production.

● Assisting with the continuous development of the current training requirements.

● Tracking and trending overall production of the sports medicine product line.

● Providing technical expertise and insight regarding the production and surgical application of sports medicine allografts.

● Assisting with the development and implementation of innovative allograft concepts.

● Training processing technicians in sports grafts (ACL/PCL).

● Holding training sessions for sports grafts during shut down week. Processing Technician, Musculoskeletal

(2013-2015), 1st. & 2nd Shift

● Perform all aspects of processing, preservation and storage of tissue in a FDA regulated Environment.

● Works in a team environment under aseptic conditions while performing controlled production processes.

● Perform quality assessments of tissue products and documentation.

● Documents all processes and functions performed in accordance with all procedures and protocols.

● Performs post production and/or post packaging documentation review and data entry according to current procedures and protocols.

● Assists supervisory team in production enhancement and improvement initiatives. Eddie Bauer

Clientele Sales Specialist

(2008-2014)

● Participated in interviewing and hiring new sales associates.

● Established and monitored store work schedules and payroll expenses.

● Effectively managed team weekly schedule consisting of side by side coaching, regular 1 on 1 feedback, and team meetings.

Restoration Hardware

Assistant Design Manager

(2007-2011)

● Resolved customers issues and complaints regarding operational matters.

● Assisted manager in recruiting diligent professionals.

● Properly trained and supervised new hires on store procedures.

● Collaborated with sales management to plan and develop effective sales strategies and to set goals and targets.

Skills, Abilities & Achievements

● Proficient at using CATsWeb database

● Proficient at data analysis using Microsoft Excel

● Proficient in computer numeric controls (CNC) operations

● Development and launched of Pre-Sutured Ankle allograft

● Development and launched FCON allograft

● Development and launched FCONNECT allograft

● Development and launched Graftlink Triple Strand (ACL/PCL) allograft

● Development and launched Cannulated Dowels allograft

● Development and launched Graftlink 2.0 (ACL) allograft

● Development and launched Costal Cartilage allograft

● Development and launched Pre-Suture Ankle allograft

● Subject Matter Expert for Sports Medicine product line

● Bill Anderson Innovation & Excellence Award (2017)

● Lean White Belt Certified (2019)

● Executive Choice Award (2020)

● Crucial Conversations Certified (2022)

● Leading at LifeNet Part 1 & 2 (2024)

References

Julius Maranan

Zoe Sorokos

Grayton Cintron (Lifenet MS Production Manager, 2nd Shift)

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