Core Expertise

Conducting external supplier audits for CFR 21 Parts 211, 820, ISO 13485:2003, ISO 9001:2008 and Eurdelex-Volume 4 in U.S., Canada, and South America. Including audit reports, audit responses and follow-up

Certified ISO 9001 Lead Auditor

Lead liaison for client and third-party audits—successfully passing many FDA and ISO audits

Guiding force for company’s ISO 13485 Certification

Accomplished technical writer adept at the creating/revising procedures for all facets of GMP/ISO facilities

Thorough knowledge of current industry standard practices, 21 CFR Parts 11, 211, 820 FDA regulations and USP General Chapters

Generating compliance plans and training for FDA, ISO, OSHA, EPA, DOT and state regulations

Creation, review, and approval of Validation and Qualification Master Plans, protocols and reports

Performing trending of all Quality Systems

Proven team-management skills—successfully guiding associates toward enhanced contributions to project objectives and company-wide goals

Senior Quality Assurance Analyst

Edwards Life Sciences., Irvine, California 5/18 – 10/18 (Contract)

Key Contributions

Creating job training curricula for transition documentation

Creating Customer property policy and revising associated work instructions

Updating DEKRA on documentation progress for quarterly update report

Providing gap analysis for ISO 13485:2003 to ISO 13485:2016 changes

Updating Global training PowerPoint presentation for QSR and ISO 13485:2016

Revising Quality Management Document Procedure for changes to legacy and new transition documents

Creating spreadsheets for where referenced legacy documents included in newly transitioned documents

Quality Management Representative

SigmaGraft, Inc., Fullerton, California 8/17 – 5/18

Key Contributions

Conducting ISO 13485:2016 and FDA Part 820 internal audits, including Post-Market Surveillance (PMS), Device History File (DHF), and CE Technical File

Creating trending metrics, action plans, and quality objectives for, and conducting Management Review Meetings

Creating deviation and OOS procedures

Revising critical Quality Management System SOPs, including Non-Conformance, Product, CAPA, Quality Manual and ISO 13485:2016

Training personnel on ISO 13485:2016, FDA Part 820, GMP; and rounding and significant digits

Quality Assurance Specialist

EKOS Corporation, Bothell, Washington 1/16 – 5/16 (Contract)

Key Contributions

Distributing training alerts and monitoring responses

Creating training distribution SOPs

Performing Gap Analysis between BTG International and EKOS Division SOPs

Closing out due or overdue CAPAs

Quality Assurance Auditor

BTG International Group, Various 1/16 – 5/16 (Contract)

Key Contributions

Researching and conducting domestic and international on-site audits

Providing pre-audit research and agendas and post-audit reports

Quality Lead

Biocompatibles, Inc. (BTG International Group Company), Oxford, Connecticut 3/14 – 12/15

Key Contributions

Leading internal audits and investigations, document control, trending, and management review meetings

Managing customer complaints, CAPAs, deviations, product returns and recalls

Conducting external supplier audits for CFR 21 Parts 211, 820, ISO 13485:2003, ISO 9001:2008 and Eurdelex-Volume 4 in U.S., Canada, and South America—including audit reports, approving audit responses and follow-up monitoring

Writing Quality Agreements for internal

BTG suppliers

Creating local and global SOPs to ensure compliance with all regulatory agency rules

Reviewing and revising existing SOPs

Performing trending on CAPAs, customer complaints, deviations and internal audits for monthly review by global QA team

Quality Assurance Manager

Innoteq, Inc., Stratford, Connecticut 9/12 – 3/14

Key Contributions

Internal and external audit reports and responses

Reviewing, approving analytical/microbiology procedures, protocols and data

Leading preparation for ISO 13485 certification by creating the following procedures and documentation:

–Quality Manual

–Product Design and Development Plan

–Master Validation/Qualification Plan

– Disaster Recovery Plan

–Risk Assessment Plan

–Quotes and Purchase Order SOP

–CAPA SOP

–Training Program for ISO 13485

Reviewing and approving calibration protocols and certifications

Researching avenues for calibration, qualification of 21 CFR Part 11 Compliance and equipment

Quality Assurance/Regulatory Affairs Manager

Irvine Pharmaceutical Services, Inc., Irvine, California 11/10 – 8/12

Key Contributions

Managing team of 12+ for all aspects of Quality Systems

Leading numerous client audits, responding to all observations

Overseeing electronic document control system, including CAPAs, SOPs, Deviations, Customer Complaints, OOSs, forms, worksheets and metrics

Streamlining QA review of final reports (Certificate of Analysis) to ensure all reviewers work from the same checklist

Final review and approval of OOSs, Deviations, CAPAs, method validation protocols, method validation final reports, feasibility studies, development reports and client method transfers

Providing responses to client questionnaires, debarment letters, USP general chapters 1225 and 1226, GMP compliance and customer complaints

Overseeing and reviewing protocols for Walk-In Stability Chambers and USP purified water systems with third-party contractors

Quality Assurance Manager

BioScreen Testing Services Inc., Torrance, California 2/05 – 4/10

Key Contributions

Overseeing quality processes for procedures, methods, equipment, validation, equipment qualification, document control, calibration, internal auditing, and training

Creating policies and procedures for 21 CFR part 11, 211, 820 compliance, USP general chapters, ISO 9001:2008 regulations, new projects and quality goals

Reviewing all trending for in-house monitoring, complaints, facility and equipment changes, CAPAs, Deviations, investigations, OOSs, etc.

Creating Master Qualification Plan, protocols

and reports for new clean room (Class 7),

including cleaning validation, spike and

recovery of normal flora

Lead liaison for 20 to 25 client audits annually, including ISO 9001:2008

Successfully passing three FDA audits leading to NDA/ANDA approvals

Successfully passing certification for ISO 9001:2008

Eliminating outside vendor services for maintenance, calibration and performance qualifications—saving the company approximately $20,000 annually

Revamping training program; ensuring all employees remain current on required documentation—leading to a decrease of 50% on missing training documentation

Overseeing integration of new equipment, facility and process changes to ensure smooth transition, including all required documentation prior to commissioning equipment/change

Quality Assurance/Regulatory Affairs Manager

Peptisyntha Inc., Torrance, California 11/03 – 2/05

Contract API Manufacturer

Regulatory Affairs Manager

PolyPeptide Laboratories Inc., Torrance, California

11/00 – 11/03

Contract API Manufacturer

Regulatory Affairs Specialist III

Grifols (formerly Alpha Therapeutic), Alhambra, California

6/00 – 11/00

Biological Blood Components

Assistant Director, Quality Assurance

Bachem California Inc., Torrance, California 11/96 – 6/00

Contract API Manufacturer

Regulatory Affairs Administrator

Golden Pharmaceuticals Inc., Golden, Colorado

6/95 – 12/95

Radioactive Pharmaceutical Manufacturer

Regulatory Affairs / Clinical Applications Specialist

Sysmex Corporation/TOA Medical Electronics 4/92 – 1/95

Long Grove, Illinois, and Los Alamitos, California

Medical Device Manufacturer

More Details on LinkedIn

(Including recommendations and endorsements)

http://www.linkedin.com/in/sopguru/

Education

Illinois State University, Normal, Illinois 1/79 – 6/82

B.S. in Medical Technology

Included clinical internships in the following laboratories: Hematology, Blood Bank, Immunology, Radioassay, Nuclear Medicine, Chemistry and Microbiology.

Contact this candidate