Open to opportunities

April Garza

@aprilgarza

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Experienced quality systems manager with a focus on compliance.

United States

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What I'm looking for

I am seeking a role that values quality and compliance, with opportunities for leadership and professional growth.

With over 15 years of experience in the Food and Drug industries, I have honed my skills in implementing and evaluating test methods and standard operating procedures that align with USDA and FDA regulations. My expertise lies in quality control and assurance principles, ensuring compliance with good laboratory practices and regulatory requirements.

Throughout my career, I have successfully managed teams of over 20 employees, developing staff goals and objectives while leading cross-functional initiatives. My role as a subject matter expert has allowed me to interface with customers effectively, investigate root causes for non-conformances, and manage budgets efficiently. I take pride in my ability to analyze training data to identify gaps and recommend solutions, ensuring that all training programs are compliant and effective.

My commitment to quality is reflected in my achievements, including leading successful audits with minimal non-conformities and implementing process improvements that have resulted in significant cost savings. I am passionate about fostering a culture of quality and continuous improvement within organizations.

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Experience

Work history, roles, and key accomplishments

Current

Sr. Manager, Document Control & Training

Current

Artivion

Jun 2021 - Present (4 years 5 months)

Responsible for multiple sites and overseeing the Document Control and Training process. Managed the Document Control system and ensured all controlled documents were properly managed throughout their lifecycle. Managed and maintained a compliant training program by utilizing an eQMS.

Document Control Data Analysis Onboarding

Compliance Manager – Investigations & Complaints

ICU Medical

May 2019 - Present (6 years 6 months)

Responsible for managing the daily operations for post market complaints and manufacturing investigations. Reviewed tracking and trending protocols to evaluate low level CAPA investigations and identify and provide oversite of any potential adverse trends. Assisted with developing and implementing process improvements for the Manufacturing Investigations Team.

Manufacturing Investigations CAPA Process Improvement

Quality Control Manager

Premier Research Labs

Apr 2018 - Present (7 years 7 months)

Performed final approval of controlled documents for regulatory compliance and technical accuracy. Developed and implemented a robust Environmental Monitoring Program to define the zone concept, leading to significant cost savings. Managed the inspection and test result approval of raw materials, in-process manufacturing material and finished products.

Quality Control In Process Testing Finished Product Testing

Analytical Services Manager / Business Unit Manager

Eurofins Microbiology Laboratories

Jun 2014 - Present (11 years 5 months)

Assisted the US Food Laboratories on technical issues related to projects, bids, and other laboratory issues. Assisted the business unit operations with customer interactions to maintain customer satisfaction. Assessed technical research and vetting new products and services from vendors.

Technical Support Business Operations Vendor Management

Quality Analyst II

DPT Laboratories, LLP

Apr 2012 - Present (13 years 7 months)

Responsible for documenting, investigating, and resolving both product related complaints and deviations; reduced cycle time of processing customer complaints from over 90 days to less than 30 days. Interfaced with business customers and provided solutions for quality issues. Responsible for mentoring and training new analysts in complaint and deviation resolution in accordance with cGMP requireme

Root Cause Analysis CAPA Mentoring

Laboratory Manager

Food Safety Net Services

Mar 2007 - Present (18 years 8 months)

Oversaw all aspects of the San Antonio Microbiology Department operation and personnel by establishing, implementing and maintaining strategies and processes that ensured compliance with USDA, FDA, cGLP, and ISO 17025 certification. Led organization by establishing and maintaining professional business relationships with clients, industry officials, and peers; ensured sample turnaround time goals

Laboratory management Operations Management FDA

Business Unit Manager

Eurofins Microbiology Laboratories

Responsible for overseeing all aspects of the largest Eurofins Food Microbiology operation in the US by establishing, implementing, and maintaining strategies and processes that ensure compliance with USDA, FDA, cGLP, and ISO 17025 certification. Responsible for establishing and maintaining professional business relationships with clients, industry officials, and peers; ensuring sample turnaround

Operations Management FDA Sample Turnaround Time Facility Transfer

Manager, Quality Systems

Artivion

Responsible for quality related systems such as CAPA, internal audits, document control, and training. Assisted in leading front / back room for several successful internal and notified body audits with only minor non-conformities. Assisted with the initial implementation of SmartSolve Apollo eQMS upgrades for CAPA, document control, and training.

CAPA Internal Audit Document Control Training Global Harmonization

Sr. Quality Systems Engineer

Artivion

Led internal audits and helped manage external audit assessments; in process of conducting cGMP walk throughs for audit preparedness. Managed the Engineering Change Notice process; developed and implemented an ECN Tracker to hold owners accountable with ECN movement on plan, implementation, and closure. Coordinated training for DocuWare/Kofax scanning to improve batch classifications for more effi

Internal Audit Externe Audits Engineering Change Notices SmartSolve Admin