CARMEN FERNANDEZ

**** ******* ****** • Midway City, CA 92655 • 714-***-**** •

ac8qdf@r.postjobfree.com

Top-Performing Quality Assurance Engineer

Specializing in Pharmaceuticals and Medical Devices

High skilled quality assurance professional with a demonstrated record of achievement working with cGMPs and SOPs through all phases of new product development from raw materials to release to consumers.

Known for developing and implementing test procedures and protocols and other process- es that improve product quality, as well as regulatory compliance.

Proven expertise in investigating customer complaints and operational problems, identify- ing deviations/root causes, and implementing corrective/preventative actions.

Successful auditor and QA representative for FDA Audits and IQ/OQ/PQ Validations.

An exceptional communicator and team builder who leads by example. Professional Experience

Vyaire Medical, Yorba Linda, CA 3/2018 - Present

Supplier Quality Engineer - Contract

- Conduct on-site supplier audits with respect to 21 CFR 820 and ISO 13485

- Wrote both protocol and report for injection molding processes

- Lead Supplier Quality Engineer on company rebranding/relabeling project. Primary responsibilities were to identify and coordinate with disparate and globally located internal teams (Quality, Engineering, Document Control, and Marketing) to determine document requirements for review and updates. Additional responsibilities included supplier engagements to coordinate internal SKU labeling change requirements with supplier change management requirements, verification of artwork, and physical mechanical branding equipment change timeline.

- First Article Quality Validation and Quality release to production.

- Delivered over 10k updated product document assessments, ECOs as well as author- ing several hundred missing SKU documents.

Life Science Outsourcing, Brea, CA 5/2017 - 11/2017 Validation Engineer -

- Lead multi-discipline product quality teams and participated in new product introduction projects.

- Monitored quality control of the products and processes and implemented improvements to enhance quality.

- Lead product quality investigations to successful conclusion

- Wrote IQ/OQ/PQ for contract manufacturing processes

- Perform Root Cause analysis and implementation of corrective action for product and process related issues

- Performed PFMEA

- Conducted Risk Analysis and Process Validation reports

- Completed Customer Complaints

- Assisted with Internal Audit Program

- Member of the MRB

DiaSorin Diagnostics, Cypress, CA, 3/2015 - 10/2016 Senior Quality Engineer -

Provide technical analysis of processes that are involved in the development of products and the manufacturing of products in order to ensure that products developed and manufactured are consistent and meets specifications. Help and support such activities while ensuring that applicable standards and procedures are followed. Mentor and train junior level Quality Engineers.

- Review manufacturing and validation activities to ensure that they are well established and compliant with the regulations.

- Perform application, design, and process FMEAs on all molecular products

- Ensure that appropriate procedures are establish to support Design Development and the Manufacturing Processes.

- Perform external audits to qualify critical suppliers

- Perform root cause analysis/CAPA for non-conforming materials/processes TRIMEDYNE INC, IRVINE, CA, 10/2013 - 3/2015 (contractor from 10/2013 through 2/2014) Quality Engineer –

Ensure both procedural compliance and satisfactory product quality at the lowest possible cost with the regulatory constraints under which the Company operates. Led Risk Management process ensuring that the quality policies, processes and controls of the Company are developed and implemented throughout the organization and are in compliance with medical device requirements.

- Process owner for the risk management process and responsible for documenting risk management activities.

- Participate with executing and ensuring compliance with Company's internal Corrective and Preventative Action (CAPA) system including initiation, periodic reporting, rout cause analysis, proposing and implementing corrections, corrective actions, and validating these actions are effective.

- Assist with ensuring compliance with the Company's internal Nonconforming Product cause analyses, proposing and implementing any required corrections or corrective actions (including modifications to products, procedures ad/or process) and validat- ing that these actions are effective.

- Responsible for the health hazard evaluation process fathering relevant, factual information and data in order to accurately complete risk management and health hazard evaluations.

WATSON PHARMACEUTICALS, CORONA, CA, 5/2013 - 9/2013 Quality Assurance Specialist III – Consultant

Responsible for investigations of deviations associated with a nonconformity or problem in the manufacture, processing and packaging of solid dosage pharmaceutical products. Performed hands-on research, analysis and technical writing duties related to work process and proce- dures. Developed, wrote and reviewed complex Deviation Investigations Reports, updated Stan- dard Operations Procedures (SOPs), Batch Records, forms and other types of technical docu- mentation as a result of Corrective Action/Preventative Actions (CAPAs) within defined time frames.

GILEAD SCIENCES, SAN DIMAS, CA, 2005 – 2011

Quality Assurance Specialist III – Manufacturing Support Develop and manage Annual Quality Reports for all manufactured cytotoxic products to ensure regulatory compliance with FDA standards. Perform manufacturing support, batch record review, and release of product. Serve as interim QA inspector for injectable product as well as solid dose tables. Lead weekly meetings to support compliance goals and ensure that root cause and action plans are created and maintained. Manage product tracking and trending systems.

̈ Enhanced product QA compliance by updating and training site-wide personnel re- garding non-compliant issues.

̈ Excelled as QA representative for FDA Audits and IQ, OQ, PQ Validations throughout facility.

Quality Assurance Supervisor (Team Lead), 06/05 - 06/06 Scheduled and oversaw team of Master Production Records reviewers to ensure timely re- lease of product, as well as goals of contract and in-house pharmaceuticals. Conducted internal and external audits and investigated issues and CAPAs to achieve site-wide com- pliance. Evaluated team performance and coordinated RGAs/deviations/lots manufacture. ̈ Documented improvements to manufacturing systems by implementing SmartCapa, a computer management system for corrective /preventative actions. ̈ Implemented Standard Operating Procedures (SOPs) for use in GMP/product impact and CAPA effectiveness.

̈ Liaison for manufacturing in-process and finished product. ALLIANCE MEDICAL PRODUCTS, IRVINE 03/04 - 04/05

Quality Engineering

Commissioned in-process, PQ stage water for aseptic processing injection systems. Con- ducted validation studies, reviewed production batch records for compliance, wrote all CA- PAs/deviation reports, and released product for consumer use. Investigated customer complaints and operational issues to identify root cause and corrective/preventative ac- tions. Conducted vendor audits and participated in regulatory agency and customers’ au- dits.

̈ Led project teams in process flow diagramming, FMEA, and risk management, in- cluding development of sampling call-outs and application of statistics for new product developments process control.

̈ Developed sampling call-outs and applied statistics to achieve process control for all new product development.

MICRO THERAPEUTICS, IRVINE, CA, 08/02 - 03/04

Quality Engineer

Accomplished validation studies on sterilization processes of ONYX, a liquid embolic sys- tem for PMA submission. Developed QA procedures supplier quality, product non-confor- mance, and test equipment calibration, including implementation of new QA process. Cre- ated QA procedures for design specifications of engineering drawings, chemical self-life, and Pyrogen/Bioburden sampling. Performed microbial challenge testing/ISTA-2A testing, investigated customer compliances, managed internal audits, and developed and main- tained quality metrics for non-conformance reports. ̈ Led risk analysis projects, contributed to aging studies, wrote quality monitoring plans and packaging validations, and created all per-design controls for new prod- uct development projects.

̈ Directed Lean Manufacturing process implementation, including establishment of AQL inspection levels, creating/writing manufacturing/quality procedures, root cause analysis and pareto analysis for defects, and writing/executing validation protocols for equipment relocations and environmental controls. ̈ Introduced plan for manufacturing reduction of inspection and monitored QC-Man- ufacturing non-conformance plan.

PALL MEDICAL, WEST COVINA, CA, 06/01 - 08/02

QA Validation Engineer

Designed and executed process validation to support new and existing final product as- sembly lines, as well as sub-assembly of components for blood bag production. ̈ Developed qualification test plans and protocols, internal quality systems, and final reports.

̈ Facilitated the transfer of Blood Bag Process from West Covina, CA to Tijuana, Mexi- co.

UNILEVER HPC, CITY OF INDUSTRY, CA, 3/00 - 06/01

Quality Engineer (2001)

Generated plant-wide cost savings by collaborating with suppliers to reduce product over- fill, improve corrugate design, and light weight bottles. Conducted statistical process con- trol (SPC) and current Good Manufacturing Practice (cGMP) training. Yellow Squad Leader for all chemical plant spills.

̈ Partnered with corporate to redesign packaging and resolve manufacturing issues. ̈ Validated rinsing, cleaning, sanitizing process for FDA-regulated OTC. Chemist/Microbiologist (2000)

Conducted analytical tests including viscosity, melting point, refractive index, Magnesium content (AA), and pH on raw materials and finished products. Tested and/or identified mi- crobial ATP of finished products and microbial contact of Total Viable Count for all raw materials.

KAL KAN FOODS, VERNON, CA, 1999 – 2000 03/99 - 03/00 Analytical Lab Technician

Performed analytical tests, including protein, moisture, fat, ash, and percent gelatinization on raw material, test products and finished products. Education

CALIFORNIA STATE UNIVERSITY, LONG BEACH, CA, 1998

Bachelor of Science in Chemical Engineering

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