Joseph Chi

 QUALIFICATIONS Quality & compliance consultant with over 20 years of working experience with multinational corporate operations and working knowledge of current U.S. Government regulations concerning: distribution, cGMP’s, 21CFR Part 820, 210, 211; 1271; MDD; ISO 13485:2016, 9001:2015; ISO 10005: 2018; ISO 19011: 2018; CAMDCAS, ANVISA, CFDA, MHLW, TGA; Quality Systems Regulations (QSR’s), MDSAP & public policies. Strong leadership proficiency and proven problem-solving adeptness with the use of powerful teambuilding skills, clear goals & metrics. Member of ASQ Audit and Quality Management Divisions. Fully trilingual (English/Spanish/Portuguese) excellent communication skills and willing to travel. WORK EXPERIENCE Joseph Chi & Associates, Inc.Miami, Florida 1996-Present Quality/Compliance Senior independent contractor and sub-contractor to the regulated industries in response to Consent Decrees, Warning Letters & form 483 Observations. Plan and execute Quality and Compliance Audits, process and equipment validations, process improvement, effectiveness verifications, quality initiative projects at all levels for manufacturing firms in North America, South America and Europe developing and manufacturing Medical Devices, Pharmaceuticals & Biotechnology for human and veterinary use. Ethicon, LLC. San Lorenzo, PR - Contract Lead Auditor for a Class II & Class III Medical Device Manufacturer. Performed internal audits on Quality System against ISO 13485:2016, Anvisa requirements, China GMPs, MDD, Anvisa; Australia TGA; CAMDCAS; MHLW; 21 CFR Parts 820, 801, 803, 806 for MDSAP Preparation and Participation. Audited Quality System in the areas of CAPAs, Nonconformances, Packaging Controls, Management Responsibility, Device Reporting; Escalations, Corrections & Removals, Advisory Notices, Labeling Controls, Document Control & Record Management. Assisted groups with guidance on identified issues in documents and processes that required changes. NuvasiveDayton, Oh - Independent contractor engaged in a technology transfer project of manufacturing processes and equipment for an implantable Spine Device manufacturer. Engaged in IQ/OQ/PQ development, execution and review and approval. BioTeknicaMiami, Florida - Quality Manager and Sr. Quality Consultant within a boutique consulting firm to the Medical Device, Pharmaceutical and Biotechnology industries. Designed, Planned and Implemented an ISO 9001:2015 QMS system. Sat for Stage I Audit with no findings. Managed all aspects of the Quality System: Internal Audits, Management Reviews, Complaints, CAPAs, Procedure development and Changes. Lead, and performed internal audits of quality system. Interfaced and managed teams as project manager with high exposure clients and engaged in Quality System remediations (remedies), audits and advising delivering projects to closure within time and within given budgets. Alpha & Omega Calibration LabMiami, Florida - Supplier Audit Performed on Calibration Lab for use by consulting firm’s measurement equipment for temperature, Rh; Voltmeters; and other calibrated equipment. Medtronic DiabetesNorthridge, California- CAPA assessments and Investigations for open CAPAs. Contributed to FDA response letter. Development of Quality Plan for closing open CAPAs. Physio ControlSeattle, WA- Lead Auditor performing Quality System Internal Audit of Purchasing Controls and Statistical Controls, per 21 CFR Part 820, ISO 13485:2016. Vyaire (Care Fusion)Palm Springs, Ca- Sr. Quality Consultant performed Quality System Audit at class II Medical Device manufacturer. Audit against 21 CFR Part 820 and ISO 9001:2008. Actavis Davie, Fl- Validation of Centralized Environmental System for pharmaceutical manufacturing site. Ethicon, SA de CVJuarez, Mx- Developed and delivered presentation on Technical Writing to Engineers and Engineering managers. ConMedTampa, Florida- Sr. Quality Consultant on a Quality System Audit for MDRs, CAPAs and Complaints, over two sites. Interfaced with executive management to report on findings and inconsistencies. Interviewed several managers and employees of the quality department. Summit Pharmaceuticals Phoenix, AZ - Interim QA Director for several months at an OTC drug manufacturer. Aided in the interviewing and selection of candidates for the QA Manager position. Hosted FDA visit to site for an unannounced audit. Developed plan to remediate 483 observations. Developed and executed IQ/OQ of their Norden Filling machine. IQ/OQ for labeling machine. Developed PQ and handed PQ execution to new Quality Manager upon hire. Reviewed packaging procedures. Reviewed deviations for generating CAPAs. Generated CAPAs due to form 483. Updated Master Production and Control Records after FDA audit. Prepared remediation plan for 483 observations. Audited suppliers for API requirements and made changes to ASL as per internal Quality System requirements. Edwards Life SciencesIrvine, California- Sr. Quality Consultant Team lead and Project Manager working on an 18-month CAPA Remediation project and FDA Audit Preparation project within a Class III medical device environment. Performed Worked closely with Executive Management on NCR’s and CAPA strategies and closing open and long overdue CAPAs within time and budget. CAPAs included product complaints investigations, investigations for quality system failures, Supplier Correcrive Action Request, Non-conformances. Managed, and tracked time and budget for the building qualification for new animal testing facility including IQ/OQ/PQ protocol developments, reviews and approvals with client management. Both Projects completed within time and given separate budgets. Watson LaboratoriesDavie, Florida- Project Manager at a Generic Drug Manufacturer updating manufacturing procedures. Reviewed and updated nineteen standard operating procedures for pharmaceutical manufacturing processes. Woodfield Laboratories Ft. Lauderdale, Fl. - IOQ Development of Vision System for filling and packaging line for solid dose pharmaceutical products. Siemens HealthcareLlanberis, Wales; Glasgow, De - Sr. Quality Consultant charged with identifying equipment for the manufacture of diagnostics reagents. Identification of equipment and processes for validation. Complaint records (Past & Present) reviewed for potential CAPA generation, and generated spreadsheet reporting of findings. Audited 52 CAPAs for correct generation, investigation and closure.  OptosMiami, Florida/Boston, Mass/Scotland- QA/RA Manager and Site Management Representative. Managed the daily quality assurance/regulatory operations for the manufacture, storage, distribution of a class II Medical Device and a class II Radiological Device. Remediated and maintained the site Quality System, including Document Control, complaint files, CAPA records, NCR’s, calibration system, supplier quality, Management Review, as well as MDD/ISO 13485:2003/CAMDCAS, ISO 14971 requirements. Managed Internal Audit process, Training, MDR’s, Supplier Audit and changes of suppliers. Contributed to 510(k) submissions for class II device. Managed site RoHS project per Directive 2011/65/EU. Coaching and mentoring. Tracked and management department budget and resource headcount. Member of Management Team for Plant Transfer to Boston, Mass.  Sandoz North Carolina- Sr. QA Consultant working on reviewing and Successfully Closing open investigations for equipment, packaging and process CAPA’s within the generic drug manufacturing process for ~300 open investigations.  Philips Healthcare, AGHamburg, Germany- Sr. Consultant working on a Quality System remediation project opening and remediating and reviewing complaints and the Purchasing Controls subsystems to identify potential reportable events. CAPA, Quality Monitoring, and nonconforming Product Team Leader and CAPA Manager leading CAPA team, remediating these systems for radiological device manufacturing and distribution (21 CFR 820, 1002, 1003, 1020, ISO 13485, ISO 14971, MDD, CMDR). Use of Six Sigma DMAIC process for the remediation process. Design Input and output anomalies assessments. Coaching and mentoring all levels of Management. Eurofarma Laboratorios                                                  Sao Paulo, Brazil- Sr. Quality Systems Consultant performing Quality System audits at a Generic Pharmaceutical manufacturer in Brazil, both aceptic and non-aceptic drugs. CAPA, Quality Monitoring and Purchasing were audited and reviewed for management to evaluate for possible product sales into the US market.    Care FusionEl Paso, TX - Sr. Consultant engaged in a Quality System Remediation project working with NCR’s, Facilities Monitoring, Destruction of Material, Solutions Reconciliation, Label Inspections, Process Validation and un-controlled Labels.  Managed each sub-project team, reviewed and revised procedures for QS sub-systems.  Involved in Coaching and Mentoring all levels of management.  • Sandoz, SA (Novartis) Buenos Aires, Argentina- Project Manager for a team performing audits, verifications, and remediation of equipment and process validations, QA reviews, product releases, Supplier Quality and Quality System reviews. Carried and tracked Project time and financials to completion within time and given budget. Reported to VP of Quality.  Laboratorios Neo QuimicaAnapolis, Brazil- Senior QA consultant engaged in the development of Quality System Programs for a pharmaceutical firm with over 900 SKU´s in Brazil seeking to market solid and semi-solid drug products in the United States. Interaction with executive management and development and implementation of Policies and Procedures for CAPA, Change Control, Non-Conformance System, Supplier Quality, Management Review, Complaint Handling & Investigations, Training, Internal Audits, Annual Product Review/ Product Release, Quality Manual, Purchasing and Acceptance Criteria, Vendor Audits, New Vendor Assessments. Performed vendor API and raw material audits and inspections for different product lines. Developed and rolled out training on new quality system policies and procedures. Review and approval of Qualification and Validation protocols for process validation.  Zimmer Orthopedic Surgical ProductsDover, Oh- Contractor QAE in a four month Quality System remediation project focusing on CAPA system, employing Root Cause Analysis developing and performing investigations, action plans and remediation of over 100 open and unresolved QA and Regulatory CAPAs, including CAPAs initiated due to recent BSI and FDA inspections. Investigated field retrievals and removals, internal audit requirements, MDD requirement s (21 CFR 803), European Vigilance requirements, Canadian Device Requirements, procedure changes, acceptance criteria, labeling changes, CAPA system requirements, calibration requirements, ISO 13485 requirements (regulatory changes to the Quality System).  Johnson & Johnson (Ethicon)Juarez, Mexico- QAE team leader in the Transfer of technology and equipment into the Juarez, Mx site from the United States. Engaged in Protocol (IQ, OQ, PQ) and Technical Assessment review and approvals, Development and execution of Test Method Validations, review and re-writing of procedures impacted by transfer. Managed the adoption of Ethylene Oxide sterilization families from the US site to the Juarez site. Evaluated Gap Assessments, Completion Reports, Technical Specifications, Process Specifications, lean manufacturing requirements and other Operating Procedures associated with the Transfer of products and processes. Tracked time and project financials to completion of delivery of project with client counterparts and management. • Alfa Wassermann, LLP.West Caldwell, NJ- Team Lead interfacing with executive management and employing Six Sigma methodology and project leadership in a six-month project involving process mapping and root cause analysis for solving Out of Box Failures at customer sites for a chemistry analyzer manufacturer. Participated in the auditing and remediation in the areas of Management Responsibility, Acceptance Procedures, Vendor/Supplier audits, Complaints, Distribution/Storage areas, in response to an FDA audit. Developed operating procedures for customer Service and technical services departments, as well as MDR related decision trees for technical services. Audited device master records for data currently being used in marketing materials. • Stiefel LaboratoriesAlbany, New York- Team Lead working on protocol development and execution of IQ/OQ’s for new Becomix ® Mixing Kettles used for the manufacture of pharmaceutical topical solutions. Development of procedures for the use of mixing kettles. Worked alongside plant management to design and execute validation plans. • MedImmuneFrederick, Md- Development of Policies and Procedures for process and equipment validations concerning the manufacture of vaccines in aceptic conditions. Development of VMP and validation schedules. Protocol development (IQ/OQ) for ovens and mixing equipment. • Orthopedic Device Corp.North Carolina- Development of Quality System Documents, Top- Down policies and procedures for an orthopedic device manufacturer for human use. · Life Cell, Inc. Somerville, New Jersey- Conducted Calibration Management System audits for a Human Tissue processing firm per 21 CFR 1271 and 21 CFR 820 for M&TE. Developed an in-house calibration implementation system for over 400 pieces of manufacturing equipment for third party contract calibration and established a calibration cycle within the new calibration management system. Abbott LaboratoriesAbbott Park, Ill. - In response to an FDA Consent Decree participated in the following 2-year project within aceptic and non-aceptic conditions: Performed audits on Corporate Policies and Operating Procedures for “Top Down” compliance. Used Six Sigma DMAIC methodology and engaged in Root Cause Analysis on several teams. Participated in the streamlining and improvement of the Out Of Specification procedures (OOS), and CAPA system. Writing of new policies & procedures for handling process deviations and on improving the Deviation Reporting System. Re-writing of the Acceptance Criteria procedures and vendor assessments. Executed temperature distribution studies of reagent columns and autoclaves.  Ivax PharmaceuticalsMiami, Florida- Performed Facilities validation for the expansion of a staging area for finished generic pharmaceuticals. Conducted a mixing validation (Process IOQ) for mixing vessels used in the manufacture of sterile generic pharmaceutical drugs for human use.  Regeneration TechnologiesGainesville, Florida- Assisted Project Engineers in the commissioning of a manufacturing site for the production of Human Tissues marketed as a device. Conducted temperature and humidity testing of Clean Rooms as part of a Facilities IOQ. Conducted IQ/OQ’s for refrigerators, walk-in freezers, lyophilizers and deep-freezers used in tissue processing, keeping with 21 CFR 1271 and 21 CFR 820.  Pharmacia & Upjohn (Pfizer)Stockholm, Sweden- Executed temperature mapping and distribution studies (OQ), and Performance Qualifications (PQ’s) for Bosch® De-pyrogenation tunnels and PLC’s used in the sterilization of cylinders for parenteral drugs in aceptic conditions for human use, and IOQ’s for autoclaves and lyophilizers for the production of pharmaceutical drugs for human use.  Johnson & Johnson (CordisCorp.) Miami, Florida, Juarez, Mexico, New Jersey, San German, Puerto Rico, - Performed compliance assessments due to a Post Approval Warning letter for a new product. Performed Software & Hardware, ERES validation (Part 11) for the Energy Management System in Miami, Florida and Juarez, Mexico. Performed software assessments for Global Laboratory equipment software compliance effort throughout worldwide manufacturing sites. Team lead for validation assessments on equipment and processes at Mexico site, performed desk audits for executed equipment & utilities validation protocols (IQ/OQ/PQ). Performed Gap assessments for TMV’s and process validations, lean manufacturing requirements for new and adopted products.  Boston ScientificMiami, Florida and Boston, Mass. - Conducted post marketing surveillance for new products and complaints by medical practitioners. Conducted facilities commissioning and IQ/OQ for an expansion and addition of new manufacturing areas, performed IQ/OQ of an Energy Management System. Executed IQ/OQ for stability chambers for holding final released products. Used Six Sigma methodology for problem solving. Development and execution of attribute and variable test method validations in response to a Corporate Warning Letter.  Andrx PharmaceuticalsFt. Lauderdale, Florida- Performed IQ, OQ for Bosch® encapsulating and filling machines used in the manufacture of generic solid dosage products. Performed mixing studies for IOQ’s for mixing vessels. Performed Facilities IQ/OQ for new manufacturing establishment used to manufacture solid dosage type products.  Beckman CoulterMiami, Florida- Performed Process & Equipment IQ/OQ/PQ for autoclaves used for the manufacture of diagnostic reagents per 21 CFR 820. Performed temperature mapping and distribution studies for walk-in stability chambers for holding final released products.  Minimed Ft. Lauderdale. Florida- Performed Equipment IQ/OQ for walk-in stability chambers, testing for temperature and Relative Humidity for holding diagnostic products.  Bausch & Lomb Pharmaceuticals Tampa, Florida- In a 6-month project, performed process IQ/OQ for an in-situ sterilization of mixing vessels used in the manufacture of sterile (aceptic) medicated ophthalmic solutions for human use. Performed IQ/OQ’s for mixing vessels used in the manufacture of sterile medicated ophthalmic solutions.  Home Diagnostics, Inc. Hollywood, Florida- Performed process and equipment IQ/OQ for equipment used in the manufacture of renal diagnostic tests kits. Performed temperature and humidity studies for custom manufacturing equipment for these tests.  Medical Analysis Systems Camarillo, Ca- In a 3-month Project assisted Project Engineers in the transfer of lyophilizers used in the manufacture of diagnostic reagents, from Miami, Florida to Camarillo, California. Installed, re-wired and conducted IQ/OQ/PQ’s on lyophilizing equipment. COUNTRY OF RESIDENCE United States EDUCATION Baccalaureate of Arts, Florida International University 2001Miami, Florida MBA, International Business, University of Miami 2006Miami, Florida Member of American Society for Quality ASQ Certified Quality Auditor Certification Number: 49205; 2014, Recertified in 2017 ASQ Six Sigma Green Belt Certification (Given by Section 1510, South Florida); 2007 CONTINUING EDUCATION ISO 9001:2015 Implementation (2016), ASQ/Dekra Certificate Number 9KTPF1109 Quality Auditing, ASQ CQA (2014) Certificate Number 49205 Compliance of Biologics & Drugs (2003) University of California, San Diego Development of Pharmaceuticals and Biologics (2003) University of California, San Diego Medical Device Law & Regulation (2003) Quality Systems Regulations (1998) Export Administration Regulations (1996)