Quality Specialist

Aida Colon

CAREER OVERVIEW

Results-driven quality auditing and total quality management systems professional with 19+ years’ experience in design, implementation, and management of Quality Control Systems in both FDA regulated medical manufacturing and food manufacturing industries. Keen ability to analyze business process nonconformities and to formulate objective and accurate recommendations for quality requirements, issues, and concerns.

PROFILE

• Experienced in ensuring all aspects of documentation are effectively controlled from design and process documentation, technical requirements, quality records, drawings, and vendor manuals through the use of customized MS Access databases.

• Proven team leader with exemplary communication, project management & presentation skills.

• Comprehensive experience in business process modeling using tools such as process map development, gap analysis, and standard operating procedure development.

• Proficient in cGMP, ISO 9001:2000; ISO 13485 auditing and documentation, QSR, 21CFR part 820 and other quality requirements. HACPP certified. SQF 2000 Practitioner Certified.

• Assisted in Validation and Verification of new product launches, utilizing IQ, OQ, PQ.

• Assisted in the submission of FDA regulatory submissions of 510k and 510k specials.

• Experienced with Corrective Action Route Cause Analysis (CAPA) and customer relation, contact and resolution.

• Set up and maintenance of record retention against Sarbanes-Oxley Compliance (SOX) compliance.

• Create and set up of documentation in accordance to HACCP and SQF requirements.

• General Accounting and office experience.

• MS Office, Siebel 7.5, Adobe, Made 2 Manage, SharePoint, Master Control, Lotus.

• Bilingual: Spanish and English.

PROFESSIONAL SUMMARY

Power Packaging, an Exel Co. Batavia, IL (Food and Packaging Manufacturing) 2010-Current

Quality Assurance Supervisor- Dry goods manufacturing environment; batching, filling and packaging

• Directly supervisor a team of 18 quality assurance technicians and staff within two shifts.

• Manage day to day monitoring of compliance records; such as incoming inspection records/material, batch records, formulas, microanalysis and testing against HACCP requirements, cGMP and FDA requirements.

• Create training systems and review training records.

• Implement CAPA system, investigate and maintain CAPA’s.

• Monitor and ensure compliance to standards within a controlled test lab.

• Test and monitor equipment and sanitation processes.

• Implement and create bi-lingual standard operating procedures against SQF, HACPP and GMP requirements and customer expectations.

• Review and analyze audit reports.

• Implement and manage the hold program.

• Maintain and validate calibration of quality lab equipment.

• Work closely with production on the review and implementation of processes.

• Provide leadership, direction and training to the plant in areas such as quality, food safety, plant safety sanitation, good manufacturing practices and customer service.

• Maintain continuous communication with all departments to assure production priorities and shortfalls are addressed in a timely manner, to not impact customer service.

• Conduct Customer, regulatory and in-house audits.

• Monitor plant performance and develop/implement action plans to understand and address areas of concern.

• Maintain a clear understanding of customer requirements.

• Create a positive working environment for all associates; one that supports continuous improvement, reinforces company philosophy and policies, and ensures that every individual is treated with respect.

• Implement the certification of SQF 2000 Level 2

• Implement 5s program within 2 quality laboratories

Empire Today, LLC Northlake, IL (Home Improvement Industry) 2006-2009

Senior Quality and Document Control Manager- Home improvement products sales/retail

• Managed the development of Standard Operating Procedures for the Customer Care Organization which consisted of 800 plus users and 1300 documents across two call centers, order management, retention & outbound teams, and national customer service teams spanning 55 plus markets.

• Directly managed a team of 4 technical writers.

• Created the Corporate Standard Operating Procedures completion plan for each quarter using MS Word, Excel and Adobe.

• Worked closely with operations managers and project managers to ensure required documentation was in place prior to software launches and new product introduction.

• Managed and ensured new product and new market system and communication requirements were in place prior to launches

• Assisted in the creation of test scripts and user acceptance testing as needed for software releases.

• Developed technical documentation for systematic processes.

• Performed audits on documentation required to be sent to customers for legal and non-conformities issues.

• Reviewed, addressed and reported discrepancies related to non-conformities with appropriate department manager.

• Performed quality reviews on completed Standard Operating Procedures prior to routine General Manager Reviews.

• Maintained Standard Operating Procedure documentation via a customized database for internal status and reporting as well as publications of finalized documents on Word and Adobe for user access.

• Reported on status of Standard Operating Procedure development on a weekly, monthly, & quarterly basis.

• Resolved any issues which impaired the completion of Standard Operating Procedures according to strict timelines.

• Identified any risks or process gaps that needed escalation & resolution in order to be resolved.

• Performed organizational gap analysis for JDPower Call Center Certification.

• Performed gap analysis for document control software vendor selection process from existing in-house application to Documentum.

• Managed and maintained the Customer Care Organization record retention schedule & monitored the program in adherence to corporate SOX legal requirements.

• Researched, created and maintained product technical guidelines for internal customers as well as Empire Today’s external website.

AngioTech Manan Medical Products, Wheeling, IL (Medical Device Manufacturing OEM) 2000-2006

Senior Quality Control Specialist- OEM Manufacturing environment injection molding and assembly

• Directly supervised a core group of Quality Internal Audit team members.

• Created and developed all internal audit documents.

• Performed initial and follow-up audits and CAPA investigations in accordance with established policies and procedures.

• Identified operational deficiencies through the audit process and provided training and development in areas of opportunity.

• Reviewed Change Requests for Quality and Regulatory deficiencies and made recommended changes and/or approvals based on established internal and external policies and procedures, as well as FDA requirements.

• Evaluated and made recommendations for improvement regarding safeguards of assists, compliance with policies and procedures, reliability of financial statements and underlying records, and efficiency and effectiveness of operations.

• Managed the document control department responsible for all master and electronic files for quality control.

• Created CFR 21 part 820 and ISO 13485 ISO 9001:2000 compliant Standard Operating Procedures and work instructions, CAD drawings and label requirements.

• Worked with multiple customers domestically and overseas to assure documentation compliance.

• Trained all levels on CFR 21 part 820 and ISO 13485; ISO 9001:2000 standards compliance auditing.

• Managed all document change request per CFR 21 part 820 and ISO 13485, ISO 9001:2000 requirements.

• Ensured all operating procedures comply with CFR 21 part 820, ISO 13485, ISO 9001:2000 and ANSI standards.

• Key player in the verification and validation program with IQ,OQ and PQ of new product and enhanced product development.

• Key player in the auditing process affiliated with the company’s regulatory body.

• Aided in the application and maintenance of FDA 510k’s and MDR’S.

• Created Test Scripts and User acceptance tested the implementation of Master Control documentation software system and Made 2 Manage ERP system.

• Created ERP Regulatory documentation against 21CFR Part 11 and other ISO 9001:2000 requirements.

General Accounting

• Performed all functions of accounts payable and receivable as directed by the Controller.

Uresil Limited Partnership, Skokie, IL (Medical Device Manufacturing) 1988-2000

Quality Control Specialist- Manufacturing of medical devices; extrusion; batching and injection molding; assembly

• Responsible for creating and developing all internal audit documents.

• Performed initial and follow-up audits in accordance with established policies and procedures.

• Identified operational deficiencies through the audit process and provide training and development in areas of opportunity.

• Evaluated and make recommendations for improvement regarding safeguards of assists, compliance with policies and procedures, reliability of financial statements and underlying records, and efficiency and effectiveness of operations.

• Developed curriculum for ISO 9000 and Internal Audit training courses.

• Responsible for research and development runs and validation/verifications standards.

• Created ISO compliant Standard Operating Procedures and work instructions.

• Trained all levels on ISO standards and ISO compliance auditing.

• Key team player for CE Marking.

• Operated and set up of extruders, milling machines and injection molding machines for the polymer processing and silicon processing of production lines and R&D runs.

• Trained personnel within the polymers processing department on extruders, injection molding machinery and milling machines.

• Batched material and mixed material in preparation of batch runs.

EDUCATION:

Robert Morris University, Chicago, IL 2003

Bachelor of Business Administration Degree in Management and Accounting

Tooling Manufacturing Association, Park Ridge, IL 2005

AutoCAD certification

AFFILIATIONS/CERTIFICATIONS:

• SAI Global SQF Practitioner Certified

• Excel Quality Internal Auditor Certified ISO 9001/2000

• SAI Global Certified against ISO 13485

• Professional Food Safety, Ltd. HACPP Certified

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