Joseph Chi

Quality Systems Manager/Senior Quality Consultant

Joseph has 15 years of quality and compliance experience within the pharmaceutical and medical device industries with working knowledge of current U.S. and European Government regulations concerning:  cGMP’s, ISO 9001, ISO 13485, ISO 19011, MDD, CAMDCAS, ANVISA, Quality Systems Regulations (QSR’s) & public policies.  Strong leadership proficiency and proven Six Sigma problem solving adeptness with the use of powerful team building skills, clear goals & metrics.  Joe is fully trilingual, and speaks English, Spanish and Portuguese.

 

EXPERIENCE…
  • QA/RA Manager and Site Quality Representative.  Managed the daily quality assurance operations for the manufacture, labeling & distribution of a Class II Ophthalmic Diagnostic Medical Device and a Class II Radiological Device.  Contributed to 510(k) regulatory submission for class II Ophthalmic device.  Managed the site RoHS project for devices per Direvtive 2011/65 EU.  Closed open CAPAs.  Program manager for the site transfer to Boston, MA.
  • Senior Quality Consultant.  Worked on reviewing and closing investigations for open equipment and process CAPA’s within the generic drug manufacturing process.
  • Program Manager and Senior Quality Systems Consultant engaged in Quality System audits at a Pharmaceutical manufacturer in Brazil.
  • Project Manager and Senior Consultant engaged in a Quality System Remediation project working with NCR’s, facilities monitoring, destruction of material, solutions reconciliation, label inspections, process validation and uncontrolled labels.  Managed each project team, reviewed and revised procedures for QS sub-systems.  Coaching and mentoring all levels of management.
  • Senior Consultant.  Worked on a Quality System remediation project in Europe; opened, remediated and reviewed complaints to identify potential reportable events.  CAPA, Quality Monitoring, and nonconforming Product Team Leader and CAPA Manager leading CAPA team, remediated the systems for radiological device manufacturing and distribution (21 CFR 820, 1002, 1003, 1020, ISO 13485, MDD, CMDR).
  • Project Manager responsible for a product quality audit and remediation project for a generic drug manufacturer for LATAM and Global markets.  Managed the scheduling and planning of roles and functions of consultant and client team members, development and updating of project plans and metrics, defining and communicating project scope requirements.
  • Senior QA Consultant and project leader managing the development of Quality System Programs for a pharmaceutical firm with over 900 SKU’s in Brazil.
  • Team Lead and Senior Contractor QAE in a Quality System remediation project focusing on CAPA system, Root Cause Analysis, developing and performing investigations, action plans and remediation of open and unresolved QA and Regulatory CAPAs.
  • Senior QA Consultant in the transfer of technology and equipment into a Mexican medical manufacturing device site from the U.S.
  • Performed compliance assessments due to a Post Approval Warning letter for a new product.
  • Investigated field retrievals and removals (21 CFR 803), internal audit requirements, MDD requirements, European Vigilance requirements, Canadian Device Requirements, procedure changes, acceptance criteria, labeling changes, Non-Conformances, CAPA system requirements, calibration requirements, ISO 13485 requirements.
  • Team Lead. Employed Six Sigma methodology of process mapping and root cause analysis for solving Out of Box Failures at customer sites for a chemistry analyzer manufacturer.  Conducted compliance audits in the areas of Complaint Handling and Distribution.  Engaged in remediation and QSR training in the areas of Management Responsibility, Acceptance Procedures, Complaints, Vendor Qualifications, Distribution/Storage areas.
  • Performed supplier audits and new vendor assessments for vendor qualification.
  • Developed Quality System documents, policies and procedures for an orthopedic device manufacturer.
  • Conducted Calibration Management System audits for a Human Tissue processing firm and developed an in-house calibration implementation system for over 400 pieces of manufacturing equipment for third party contract calibration.
  • In response to an FDA Consent Decree at a diagnostics manufacturing company, participated in audits on corporate policies and operating procedures for “Top Down” compliance.  Participated in the enhancement of the Out Of Specification procedures (OOS) including development of new policy & procedures for handling process deviations and on improving the Deviation Reporting System.
  • Performed software assessments for global laboratory equipment software compliance throughout worldwide manufacturing sites.
  • Conducted post marketing surveillance on new products and investigated any complaints by medical practitioners.
  • Development and execution of attribute and variable test method validations.
  • Performed IQ and OQ for encapsulating and filling machines used in the manufacture of generic solid dosage products.
  • 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.
  • 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 executed IQ/OQ/PQ’s on lyophilizing equipment.
POSITIONS HELD…
  • Quality Systems Manager & Senior Quality Consultant – BioTeknica, Inc.
  • QA/RA Manager – Optos, plc
  • Senior Quality Consultant – BioTeknica, Inc.
  • Senior Quality Consultant – Independent
EDUCATION…
  • M.B.A. – University of Miami
  • B.A. – Florida International University
CONTINUING EDUCATION…
  • Quality Auditing, ASQ CQA (2014)
  • Development of Biologics (2003)
  • Development of Drugs (2003)
  • Compliance of Biologics and Drubs (2003)
  • Medical Device Law & Regulations
CERTIFICATIONS…
  • Six Sigma Green Belt