Roman Garcia - ASQ Certified Quality Auditor (CQA)

Experience

• 

  Walgreens

  Aug 2008 - Jul 2011

  Pharmacy Technician
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  Stepan Company

  Dec 2011 - Mar 2017

  • Scheduling production of 2 million pounds of finished goods per week• Coordinating production schedules to fulfill an average of 20-40 customer orders per week• Contributed to 98% on time delivery to customers, including 700,000 lbs of packaged goods• Leading a group of 4 Production Assistants and 7 Production operators • Recording raw material inventory to manufacture final goods and packaged goods• Reworking 200,000 pounds of restricted inventory and sold at full value • Initiate 2 LOTOs per day to provide a safe work environment for maintenance to support production• Working 12 hours per week in lab and 40 hours per week in production to fill labor gaps Show less • Performed analytical testing on raw materials and finished goods and contributed to our 95% on time service • Quantified 12-20 carbon chain alcohols in various finished goods and raw materials using Agilent 7890 GC• Calibrated pH meters daily and calibrated Agilent 7890 GC when calibration standard fell above or below 10% of acceptable limit• Quantified organic solids in process waste water using gravimetric analyses to assure compliance with city requirements• Championed Agilent 1260 and 1100 series HPLC to quantify preservatives in cosmetics• Wrote Quality Work Instructions to maximize performance of FTIR and HPLC• Cleaned HPLC columns when contaminants were eluting from the column • Aseptically sampled process water and city water once a week to analyze microbial and chemical contaminants• Contributed to a microbial program that had a 100% customer satisfaction rate• Initiated chemical dilutions and chemical build ups to meet manufacturing specifications of each product• Lead technician for internal ISO 9001 audits• Trained 5 new specialists on lab techniques, microbial testing, LIMS, and the sulfonation process• Placed in charge of ordering lab chemicals while working to minimizing expenses• Observed ISO 9001 compliance while delivering accurate chemical and microbial results Show less

  • Production Team Leader

    Apr 2016 - Mar 2017

  • Quality Assurance Laboratory Specialist

    Dec 2011 - Apr 2016
• 

  Allergan

  Apr 2017 - May 2020

  Senior Quality Control Analyst

  • Successfully managed and reviewed all testing for all Raw Materials needed for phase III clinical batches.• Assessed Quality Agreements and Master Service Agreements related to contract laboratories for compliance purposes. • Successfully validated an impurity method via HPLC as part of a method remediation effort to submit to the FDA• Validated 5 instruments in the QC Laboratory to meet GMP and/or 21CFR Part 11 Guidelines • Lead analyst to implement a new LIMS system in the Quality Control Labs• Collaborated with Quality Assurance to improve processes through SOP revisions and reduced pipette related deviations by 60%• Developed Phase II investigation plan for an Out Of Specification (OOS) result reported by testing lab • Performed routine environmental monitoring (EM) of manufacturing facilities to clear for production activities• Qualified in analytical testing methods including, HPLC, conductivity, Total Organic Carbon (TOC), Capillary Electrophoresis, qPCR, Nitrates, Bioburden, and endotoxin testing Show less

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  AbbVie

  May 2020 - Jul 2021

  Senior Quality Control Analyst

  • Successfully managed raw materials and their life cycle for qualification/release to support production timelines• Maintained and Coordinated the updates of MSAs and QAG for Approved Vendors utilized by Quality Control• Supported the Qualification and Validation of an HPLC Assay in a cGMP environment for FDA submission• Participated in internal audits for sister site to follow up on CAPAs and effectiveness• Lead representative for the implementation of new LIMS system for the Biologics QC department• Validated 4 QC Laboratory Instruments while being 21CFR Part 11 Compliant • Implemented CAPA to reduced pipette related deviations by 40%• Developed Phase II investigation plan for Out of Specification (OOS) results reported by testing lab to close out a Laboratory Investigation Record• Performed routine environmental monitoring in ISO 7 and 8 in the manufacturing facilities • Qualified in analytical testing methods including, conductivity, Total Organic Carbon (TOC), Capillary Electrophoresis, qPCR, Nitrates, Bioburden, and LAL supporting the QC department Show less

• 

  Bausch + Lomb

  Aug 2021 - Apr 2022

  Quality Control Specialist II

  • Leveraged prior experience to self-train on Approved Procedures in the lab including Size Exclusion, Ion Chromatography, and Specific Enzymatic Activity Assays• Supported CAPA to retrain new analyst on Enzymatic Activity Assay• Generated reports for annual EM and for requalification of internal references standards• Co-qualified internal reference standard for enzymatic activity assay used for in-process, release and stability• Improved process of certain assays in which the procedures where not current• Tested back logged release lots and stability lots for the Irvine site Show less

• 

  AbbVie

  May 2022 - Jan 2023

  Senior Quality Control Analyst

  • Assessed Data Integrity Issues Pertaining to validated lab instruments• SME for PCR assay during Mock FDA audit performed by corporate Abbvie• Part of Quality Control Team that obtained FDA Approval for modernized method testing for Drug Substance Release and Stability Testing

• 

  Stepan Company

  Jan 2023 - Jan 2024

  Quality Assurance Manager II

  • Oversee and manage the quality operations, ensuring compliance with ISO 2015:9001 Standards and Industry standards.• Facilitated Document revision/new documents via the Stepan Management System (STEMS).• Drove initiative to update document owners and authors to ensure current personnel were responsible for their respective documents.• Reported Weekly and Monthly KPIs such as Restricted Inventory Generation/Customer Complaints/Quality Returns/CAPA completion Rate/Overdue CAPAs• Used cGMP experience to implement new procedures including rounding and significant figures SOP for lab use.• Heavily utilized SAP Quality Management for product traceability/new product deployment/SQC analysis of In-process and Final inspection test analysis.• Increased product volume per batch while maintaining product quality by water addition.• Lead the site to Distress sell/re-blend over 500,000lbs of OOS material per Stepan’s procedures and appropriate risk management.• Worked with customers to maintain transparency regarding product issues and obtain shipping authorizations.• Investigated customer complaints assuring manufacturing standards and quality standards are met or improved if needed.• Develop and implement procedures to enhance overall product quality and efficiencies.• Lead a team of 6 unionized quality assurance specialists, providing guidance and support to ensure accurate and efficient testing and analysis.• Collaborate with cross-functional teams to address quality-related issues, implement corrective actions, and drive continuous improvement initiatives.• Updated/renewed disposal procedure for laboratory retain samples to comply with EHS&S standards. Show less

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  Cryoport Systems

  Jan 2024 - now

  Quality Compliance Specialist