Carmen I. Pedraza

**** ***** ****** *** ***

Denver, Colorado 80205

787-***-**** / - Email: ac4ir9@r.postjobfree.com 1 1

QUALITY ASSURANCE SUPERSIVOR, AUDITOR, VALIDATIONS PROFESIONAL Highly accomplished Quality Assurance and Auditor Professional with 15+ years of demonstrated achievements in directing operational improvements for multimillion-dollar companies. Superior strategic planner known for directing highly effective teams to consistently achieve business goals aimed at ensuring exceptional productivity and full regulatory compliance. Computer literate in Microsoft Office, and possess certification in the calibration of laboratory instruments. Perform root cause analysis through investigations for client complaints, return goods or out-of-trend, utilizing quality tools

(Is/Is Not, Ishikawa Method (fish-bone), Kepner-Tregoe’s 5 Why’s and gap assessment, resulting in effective corrective and preventive actions (CAPA). TECHNICAL ANALYSIS • TEAM LEADERSHIP, MENTORING & TRAINING • REGULATORY COMPLIANCE PROBLEM SOLVING • PROJECT MANAGEMENT • QUALITY ASSURANCE • SIX SIGMA-GREEN BELT ISO 9001 & 14001 & OHSAS 18001 PROCESS • STAFF DEVELOPMENT • CI TECHNIQUES CERTIFIED INTERNAL AUDITOR • SPC • CGMP • CUSTOMER SATISFACTION • CLIENT SERVICES. ISO13485, FDA CFR PART 820 . ISO 17025.

EXPERIENCE:

STERI-TECH, SALINAS – PUERTO RICO SEPT-2017 TO DEC 2017 DOCUMENTATION SPECIALIST

Evaluate Ethylene Oxide processing documentation for compliance with customer’s process specifications and cGMPs. Keep tracking and evaluate process and procedure deviations, investigations and root cause identification. Evaluate and investigate customer complaints and CAPAs. Present data analysis at Management Review meetings. Maintain the Document control program, including revising and creating procedures and corresponding forms for the Quality Assurance and processing areas. In charge of personnel training and records update. Plan and execute internal and supplier audits identifying areas of opportunity on both. Maintain the Audit Program. Participate with Quality Manager in Customers and Certification Agency Audits, and prepare audit response plan, as assigned. ALTOL ENTERPRISES - PONCE, PUERTO RICO OCT-2014 TO AUG 2017 LABORATORY ADMINISTRATOR

As administrator, serve customers and suppliers. Ensure that sales reps meet projections and sales quotas. Inventory Management and the purchase of the means used in the microbiology laboratory for fulfilling customer services, certification and regulations. Ensure compliance with certifications microbiology laboratory. Achieve customer compliance with the contracted services in accordance to the certifications and regulations in place. Maintain contact with customers to identify special needs which may result in additional service opportunities for the Laboratory. Follow up on purchase order and inventory of equipment, solvents and materials needed for Laboratory operation. Implementation of changes in the methods governing the operations of the Laboratory, implement and ensure they comply with established policies. Attend and participate in processes of internal and external audits. Providing solutions to operational problems implementation and verify solutions. Carmen I. Pedraza

2120 Blake Street Apt 211

Denver, Colorado 80205

787-***-**** / - Email: ac4ir9@r.postjobfree.com 2 2

CADILLAC UNIFORM - BAYAMON, PUERTO RICO NOV 2013 TO OCT 2014 QA SUPERVISOR/CLEAN ROOM

As Quality Supervisor assure that all sanitization and sterilization activities meet the standards established and be in compliance with clients requirements (primarily Medical Devices and Pharmaceutical Industries). Internal audits through the calibration, training, procedures and testing programs in place to determine tendency monitored over quality metrics. HOSPIRA, ROCKY MOUNT - NORTH CAROLINA MAY 2013 TO OCT 2013 COMPLIANCE CONSULTANT

Data integrity of Visual inspection in parenteral medical device components through Knapp Study tests in order to qualify the automated process of inspection in new equipment. Evaluate qualification documents such Validation Plan, URS, FRS, and IOQ Reports. Evaluation of Non Conformances, Complaints and CAPA’s in accordance to CFR 820 Quality Systems requirements. COCA –COLA - CIDRA – PUERTO RICO JAN 2011-APRIL 2013 QUALITY CONTROL SUPERVISOR:

Project Leader for the ISO 22000 and ISO 9000, implementation in consumer products (water, juices, vitamins, energy drinks). Development and successful implementation of the HACCP program passing the levels certification requirements. Implement the analytical and in-process methodology monitoring tests during the manufacturing process. Assure the compliance of different franchises requirements in order to maintain the laboratory test reliability including the safety, quality and productivity of laboratory personnel. Review and approve all laboratory reports on a daily basis. Perform Process Capability evaluation of the manufacturing activities. .Maintain laboratory procedures and training in place. Audit the maintenance and verification executions of laboratory equipment. Assess issues for investigations in Quality Control using a CAPA system. Perform microbiological test and reports for water manufactured at Cidra Pet Plastics site. (Harmonization between site and sister companies throughout Puerto Rico)

NIELSEN COMPANY Nov 2009-Jan 2011

Multinational Research Company dedicated to stratify and analyze samples and population in accordance to data collected from medical, consumer, researchers among others. Quality Control-Statistical Analyst

Using Statistical software and tools analyze data and perform forecast to determine the shelf life of consumer products. Segregated results in frequency, histograms and failure distributions. Establish remediation plan in accordance to data behavior to avoid recurrences. Medtronic Inc. – Juncos, Puerto Rico Dec 2008-Nov 2009 Medtronic is a manufacturer of high volume medical devise products for the heart, head and body. Incoming Inspector (Interim Project)

Mc Neil, Las Piedras, Puerto Rico Oct-2008-Dec 2008 Mc Neil Consumer Healthcare is a pharmaceutical company belonging to the Johnson & Johnson healthcare products group.

Quality Control Auditor (Interim Project)

Carmen I. Pedraza

2120 Blake Street Apt 211

Denver, Colorado 80205

787-***-**** / - Email: ac4ir9@r.postjobfree.com 3 3

Rexam Inc. - Las Piedras, Puerto Rico Jul 2008-Oct 2008 Rexam is packaging material manufacturer of plastics, saran and corrugates. The materials are used in food, medical device and pharmaceutical industry.

QA Manager (Interim/Maternity Leave Coverage)

Alcan Packaging Puerto Rico, Inc. – Cayey, Puerto Rico Aug1992-Apr2008 Alcan is a manufacturer of blow and injection molding for the medical device and pharmaceutical manufacturing industry. (Note: Primary Management Experience) QA Supervisor

COMPETENCIES

Supervisory Skills

• Supervised up to twenty-four (24) persons responsible for product quality in the incoming, in-process, and final inspection

• Maintained a constant tracking of employee performance issues and intervened to correct deficiencies or recognize performance within a progressive discipline environment.

• Trained in the use of problem solving tools such as Six Sigma, Statistical Process Control (SPC), use of Flow and Fishbone Diagrams, Pareto Charts, and Corrective and Preventive Actions (CAPA), and Consultative Decision Making.

• Conducted investigations related to customer complaints by researching customer product criteria and specifications, database and batch records, and tendencies such as ignored production problems.

• Receive and approve client specifications for each product to be made. Responsible for reviewing, modifying, and documenting changes in specifications with client consent, coordination with scheduling, and coordinating with purchasing to ensure proper purchases.

• Developed training modules for each particular work group on Standard Operating Procedures (SOPs) and other topics using PowerPoint presentations.

• Visited customer sites to investigate particular situations arising from production problems or in the process of improving work processes. Attend to visiting clients to perform weekly routine audits.

• Audited and certified suppliers to reduce costs, improve quality and minimize inspections (paper, cartons, printing press) ensuring that suppliers had in place appropriate pest control mechanisms. EDUCATION AND CONTINUOUS EDUCATION

University of Puerto Rico – Cayey Campus

Bachelors of Science – Concentration in Biology – minor in Management Biotechnology Course – UPR – Cayey Campus

Training – ISO 9001, 14001, cGMP, SAP, Six Sigma Calibration Certified