Quality Control Assurance

Veronica Castro

Cell: 714-***-****

Email: ***************@*****.***

PROFESSIONAL SUMMARY

Highly motivated and results-oriented professional with extensive experience in manufacturing, quality control, and environmental monitoring. Proven track record of successfully managing projects in high-pressure, deadline-driven environments while ensuring compliance with cGMP, safety, and regulatory standards. Skilled in data review, quality assurance, and project coordination. Adept at implementing systems to optimize production and quality, with a strong background in aseptic processes, documentation management, and team collaboration. Fluent in both English and Spanish.

PROFESSIONAL EXPERIENCE

Gilead Sciences — Environmental Monitoring Data Reviewer / Quality Control Document Coordinator

June 2014 – November 2024

•Reviewed and ensured accuracy of fill/unload data and personnel monitoring qualifications (ISO-5 Room).

•Managed routine qualifications, recertifications, and operational qualifications (OQ’s/PQ’s) for various systems, including utilities (N2, CDA all test attributes, Water Samples for WFI, RO, PS all test attributes LAL, Nitrogen, Bio-burden, TOC, etc.).

•Coordinated the issuance and return of logbooks and data files, ensuring timely archival into company vaults and offsite storage for long-term retention.

•Led the 6S Program coordination and earned Yellow Belt certification in Lean Six Sigma methodologies.

•Utilized software programs such as LIMS, LES, and LES-ME for data tracking and management.

On Assignment Staffing (TEVA) — Microbiology Laboratory Technician

November 2012 – May 2014

•Conducted personnel monitoring in ISO-5 and ISO-7 environments.

•Performed Gram staining and utilized LIMS for sample tracking and data entry.

Avrio Biopharma — Senior Quality Assurance Associate (Manufacturing Support)

July 2012 – October 2012

•Maintained and tracked documentation for manufacturing operations.

•Supported the QA team by ensuring compliance with all regulatory and manufacturing requirements.

•Oversaw receiving inspections, quarantining, and releasing parts, components, and chemicals for production.

•Worked in aseptic filling and compounding of medical devices.

•Performed assembly and ensured quality standards were maintained throughout the production process.

Pyramid Labs, Inc. — Quality Control Environmental Technician

March 2010 – March 2012

•Set up and maintained environmental monitoring activities for GMP-compliant fill/finish operations.

•Performed water system bio-burden testing and laboratory documentation.

•Conducted autoclave validation testing, air velocity monitoring, and biological indicator testing.

Allergan, Inc. — Laboratory Technician

December 2006 – December 2008

•Supported the R&D department in aseptic filtration and filling operations within a Class 100 environment.

•Performed inspections related to batch-filled weight, torque testing, and visual inspections.

•Completed routine equipment setups and changeovers for sterile and non-sterile products.

•Responsible for validation of filling equipment (IQ, OQ, PQ) and batch record completion.

Kimco (Allergan) — Laboratory Technician – Clinical Packaging

March 2006 – December 2006

•Prepared and shipped over 1000 shipments of investigational medication annually.

•Applied labels, organized supplies, and ensured compliance with regulatory standards.

•Inspected labels and developed packaging guidelines and SOPs.

Amgen, Inc. — Environment Support Technician I

July 2003 – September 2005

•Performed cleaning and sanitization activities in compliance with regulatory standards.

•Trained staff in autoclave operations and aseptic cleaning techniques.

•Maintained records for GMP compliance and cleanroom environment.

SKILLS & CERTIFICATIONS

•Software Proficiency: Microsoft Office (Word, Excel, PowerPoint), LIMS, Live Link, Schedule+, LES-ME

•Languages: Fluent in English and Spanish

•Certifications:

Yellow Belt Lean Six Sigma

cGMP Compliance

Aseptic Gowning Certification (Amgen)

•Core Competencies:

Environmental Monitoring & Data Review

Quality Control & Assurance

Project Coordination & Document Management

Regulatory Compliance (FDA, cGMP, ISO)

Personnel Monitoring & Qualification

EDUCATION

High School Diploma

In addition to formal education, possess over 23 years of hands-on experience in GMP (Good Manufacturing Practice) environments, specializing in quality control, environmental monitoring, and regulatory compliance.

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