Manager Quality Assurance
Resume:
Angela Wrenn-Cardenas
******@*****.***
Profile
Experienced and results-driven Quality Manager with expertise in creating and maintaining quality systems, Standard Operating Procedures, training programs, and corrective procedures, including complaint investigations, corrective and preventative actions, and timely follow-up with management and customers.
Experience with warehouse procedures, systems and inventories. Strong ability to apply Hazard Analysis and Critical Control Points (HACCP) concepts and train others in Food Safety. Effective working knowledge of wet mill manufacturing. Thorough knowledge of ISO 9001 and PAS 22000 implementation, and accustomed to frequent third-party and regulatory audits. Experienced with FDA processes, including 21CFR210,211,110,111 light familiarity with USDA. Strong familiarity with DOT, EPA and OSHA.
Creative and analytical problem solver with equipment and process troubleshooting skills. Extensive experience streamlining processes to increase production efficiency and decrease variations. Passionate leadership style focused on diversity, effective communication, and results.
Expertise
• 21CFR110,111,210,211
• Familiarity with Q7A GMPs for API
• Familiarity with Statistical Process Controls
• EPA Testing Methods
• Familiarity with AOAC, FDA-BAM, USP Methods
• ISO 9001/Food Safety & OSHA
• ISO 9001 Auditor
• PAS 22000
• HACCP
• Food Safety-SQF
• Thermal Processing
• Clean In Place (CIP)
• Hazwoper Supervisor/Rescue Teams
• Confined Space Entry
• Safety Training, Investigations and Recognition.
• Initiation and implementation of Corrective and Preventative Action reports
• Instrument troubleshooting and calibration
• Government and third-party audits
• Documentation
• Variance Investigation
• Training
• Mock recalls and traceability
• Reducing documentation errors and variances by up to 85%, lowering costs
• Improving operator efficiency and productivity, reducing overtime costs
Professional Experience
Corn Products, Intl. - Stockton, Ca 2010 to 2011
Lab Manager
• Managed lab personnel, including reviewing, evaluating and optimizing workload and performance
• Reviewed and approved analytical data
• Identified, investigated and resolved discrepancies in order to release or hold product
• Maintained and monitored equipment calibrations, including maintenance on lab equipment
• Coordinated and led internal and external audits
• Provided technical assistance to operations as needed
• Investigated and resolved customer discrepancies, while working directly with the customers
• Performed QA/QC Manager duties in his absence
• Attended morning and monthly manager meetings
• Prepared, submitted and modified lab budget
• Created and updated SOP’s, Work Instructions, Work Aids and lab training presentations.
• Performed and trained in equipment calibrations and analysis (oil extraction) weekly and monthly
• Trained in microbiological testing and swabbing
AMPAC Fine Chemicals – Rancho Cordova, California 2008 to 2009 (laid off)
Quality Assurance Manager, Operations
• Implemented QA tracking process and improvement plan, coordinating with operational management
• Monitored all compliance and SOP training
• Led the Cleaning Optimization Team
• Successfully maintained and improved product quality by completing regular product and process audits; investigated customer complaints; collaborated with other members of management to develop continuous improvement processes
• Involved with customer and FDA audits
• Planned, scheduled and implemented training for new hires, line staff, and management
• Created new training tools and helped develop new policies, procedures and process flows
• Coordinated, implemented and maintained records of internal employee training
• Developed plan to generate QA SOPs for new processes in alignment with the Quality System
• Prepared quality documentation and reports by collecting, analyzing and summarizing critical quality information and communicating it to key team members
• Initiated and pursued Corrective and Preventative Actions, Variances and Batch Record Corrections
• Developed quality metrics, tracking systems, and management presentations to evaluate progress
• Inspected process areas and product for cleanliness, contamination, process failure or variances
NOR-CAL Beverage Anaheim, California 2006 to 2008
Quality Assurance Supervisor
• Led ten Laboratory technicians and one Lead in analytical methods and line checks
• Sampled and inspected railcars and incoming trucks.
• Gained experience with warehouse procedures, systems and inventories
• Organized lab and procedures
• Solved analytical problems and batching issues
• Created logs and check lists to ensure that quality objectives were being achieved
• Helped commission new products and lines
• Trained in and enforced GMP requirements
• Used troubleshooting and analytical skills extensively
• Gained experience with FDA, EPA, OSHA, Coca Cola and Silliker audits.
• Monitored lot numbers for traceability
• Identified and implemented process and quality improvements
• Monitored and updated quality audit system to ensure ongoing quality compliance
• Applied HACCP Principles
• Created and maintained Allergen program
• Worked with other department managers on Sanitation and Wastewater
• Simulated and diagrammed processes, equipment troubleshooting, and problem solutions
• Assisted in equipment changeovers
• Reduced quality issues from 20% to less than 10% for all three production lines
• Created quality vs. production data sheets to increase production, maintain quality, and lower costs
• Predicted quality issues to minimize the costs of reprocessing or reworking
Dow Chemical Torrance, California 2001 to 2006
Laboratory Manager/Production Supervisor
• Implemented procedures for pharmaceutical and cosmetic regulations
• Controlled and monitored all laboratory and production functions
• Maintained customer deadlines
• Created shipping documents and performed inventory checks
• Maintained health and safety via meetings and training
• Prepared audits for corporate
• Performed quality systems verifications
• Maintained and updated Standard Operating Procedures
• Prepared for FDA and cGMP audits and met with FDA auditor
• Prepared for EPA audits and met with EPA auditor
• Performed analysis and reported analytical values
• Calibrated and maintained Gas Chromatograph, Titrator, and UV/IR
Del Mar Analytical, Irvine, California 1999 to 2001
BTEX Extraction Technician/Analyst
• Gained extensive experience in efficiently loading and unloading railcars
• Performed extraction and analysis of environmental air, water, and soil samples
• Interpreted and reported data
• Learned and used EPA methods (diesel, BTEX, 413/418, 8260, 8270/625)
• Acquired familiarity with GC/GCMS, IR, UV
Laboratory Equipment:
• High Performance Liquid Chromatography (HPLC) - Waters/Alliance, Shimadzu
• Gas Chromatography (GC) - Perkin Elmer, Hewlett Packard
• Total Organic Carbon (TOC) - Shimadzu (5000 and 4110)
• Refractometer
• pH meter
• Conductivity meter
• Viscometer - Brookfield
• Moisture Analyzer - Mettler Toledo
• Combustible protein analyzer (Kjeldahl method) - Elementar
• Microscope
Computer Skills
• System Analysis and Program Development Software (SAP)
• Laboratory Information Management System (LIMS) - LabSoft
• Microsoft XP and 2007
• Lotus Notes
• Computer Based Training (CBT) – ClarityNet
Education
California State University, Fullerton - Fullerton, CA
Master of Science in Biotechnology, 2012 (projected)
Master in Business Administration, 2012 (projected)
Bachelor of Arts (B.A.) in Chemistry, 2000
G.P.A. 3.7
Minor: Math (Specialize in Advanced Calculus and Statistics)
Minor: Physics (Specialize in Vector Dynamics, Motion and Optics)
Mechanical Engineering courses: Fluid Thermodynamics and Computer programming
Electrical Engineering courses: Vector Analysis and Electric Circuits
Citrus College - Glendora.CA
Associate of Science (A.S.) in Natural Sciences, 1996
G.P.A. 3.5
Emphasis: biochemistry and forensic pathology
Professional Development
AIB Certificate in Hazard Analysis and Critical Control Point (HACCP)
AIB Certificate in Good Manufacturing Practices (GMP) and Sanitation
Six Sigma training
Hazwoper Supervisor Certified
First Aid, CPR and AED Certified
Confined Space Entry Permit – Certified
Supervisor and Manager training
Effective communication and management training
Professional Affiliations
American Chemical Society (ACS)
American Society of Quality (ASQ)
Contact this candidate