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Click here or scroll down to respond to this candidate997 Viewpoint Dr
Lake in the Hills, IL
Street Address
PHONE NUMBER AVAILABLE
EMAIL AVAILABLE
, ASQ CQA, RABQSA CLA
Candidate's Name
Summary of
Qualifications
Experienced international and domestic auditor and audit manager. Have led
numerous DMAIC and Lean initiatives. Extensive experience in project Coordination,
facilitation, and project leading. Extensive knowledge and implementation history with
FDA CFR 210, 211, 606, & 820, AAMI and ISO 13485, 9001, 11137 (Ethlyene
Oxide Sterilization), & 11135 (Gamma radiation sterilization). Very proficient in
Microsoft Word, Excel, PowerPoint, SharePoint, ETQ, MetaWeb, Trackwise, and
Access. Extensive QLP, Six Sigma, & lean management training. Extensive
experience with federal, state, and European audit leading, hosting, and compliance.
Skilled in CFR Part 11, 58, 210, 211, 606, & 820; ISO 13485 & ISO 9001 auditing, audit
creation, development, and execution. Experienced with FDA 483 response, warning
letter, and Consent Decree remediation processes. cGMP, GDP, GLP, & class
100/10,000 sterile environment qualified.
Education
Bachelor of Science, Criminology
Indiana State University
Certifications
Terre Haute, IN
Affiliations
American Society for Quality, Certified Quality Auditor (CQA) - License# 40928
RABQSA, ISO 13485/9001 QMS Certified Lead Auditor License# 129157
Certified cGMP Instructor
Six Sigma Yellow Belt
United Way Safe & Stable Families Allocation Committee member
Association for the Advancement of Medical Instrumentation (AAMI)
American Society for Quality (ASQ)
Delta Sigma Phi
Professional
Experience
10/2012 Present: STERIS Healthcare Corporation, Isomedix
Quality Systems & Regulatory Compliance Validation & Audit Manager
Ensures Quality Systems/Regulatory Compliance for the development
and/or expansion of STERIS Isomedix facilities including project design
concepts and implementation strategies. Leads and manages STERIS
Isomedix software validation program, providing business unit guidance for
validation and 21CFR part 11 compliance. Subject matter expert for validation
and document requirements for equipment, system and software validation.
Directs and oversees the planning and initial development of new facility and/or
expansion projects, providing direction for quality and regulatory needs, and
identifying and communicating quality and regulatory resource requirements.
Manage and lead the Business Unit & Internal audit programs for 18
Isomedix facilities including both Gamma irradiation and Ethlyene Oxide
sterilizers in the US, Canada, and Puerto Rico, as well as the Supplier Audit
Program for 54 suppliers across North America and Europe. Design, lead,
execute, and implement FDA CFR 820,210, & 211, AAMI and ISO 13485, 9001,
11137, & 11135 audit plans and programs. Remediate FDA 483 audits and
responses across all facilities. Project leader for audit implementation and
design of the electronic management system. Subject matter expert and SOP
owner for Business Unit Auditing, the Supplier Audit Program, Internal Audit
Program, & SAR Process. Track & trend metrics across the division as well as
through individual facilities. Lead, develop, & instruct the Internal Auditor training
program. Responsible for ensuring division compliance to all US and foreign
regulations, laws, and standards.
Quality Systems & Regulatory Compliance Audit Program Manager
Manage and lead the Business Unit & Internal audit programs for 18
Isomedix facilities including both Gamma irradiation and Ethlyene Oxide
sterilizers in the US, Canada, and Puerto Rico, as well as the Supplier Audit
Program for 54 suppliers across North America and Europe. Design, lead,
execute, and implement FDA CFR 820,210, & 211, AAMI and ISO 13485, 9001,
11137, & 11135 audit plans and programs. Remediate FDA 483 audits and
responses across all facilities. Project leader for audit implementation and
design of the electronic management system. Subject matter expert and SOP
owner for Business Unit Auditing, the Supplier Audit Program, Internal Audit
Program, & SAR Process. Track & trend metrics across the division as well as
through individual facilities. Lead, develop, & instruct the Internal Auditor training
program. Responsible for ensuring division compliance to all US and foreign
regulations, laws, and standards.
08/2005 10/2012 Baxter Healthcare Corporation
Global Compliance Associate II, R&D Quality System & Compliance
Subject matter expert and SOP owner for Technology Resources
Nonconformance and CAPA processes within the quality system. Lead, coach,
facilitate, execute, and manage all Nonconformance, CAPA processes, and
investigations. Project leader of the Business Excellence program. Project
leader and manager of the Quality Systems Management Review Process
within Technology Resources and TR Quality. Project leader and facilitator for
the Technology Resources CAPA review board. Facilitator and coordinator of
the OOL/OOT impact statement program. Lead cGMP trainer for Technology
Resources and TR Quality. Member of the Global Compliance Consent Decree
audit team. Responsible for developing, revising, and reviewing SOPs and
procedures as well as the tracking and trending of all quality system and
regulatory metrics within Technology Resources and R&D Quality.
Accomplishments: Implemented a redesigned R&D MRM process, reducing 45 applied
man hours per process. Developed a process for OOT/OOL tracking and trending within
TRQ. Designed, implemented, & led the CAPA Review Board project successfully
integrating R&D quality departments from the US, Belgium, Grosotto, and Malta into one
harmonized quality system.
Quality Management Representative, BioScience Division
Responsible for leading and managing quality operations for the
Bloomington area, as well as 30+ employees. Design, execute, and maintain
facility wide improvement plans. Track and trend all facility/employee metrics.
Host and lead all federal, European, and state regulatory audits. Perform 12+
internal facility and employee wide audits per year. Ensure facility & employee
integrity as well as adherence to federal regulations, and SOP guidelines.
Facilitate monthly employee staff meetings. Design, lead and complete company
investigations. Design and implement federal, state, and European audit
responses. Head of the quality committee. Design and execute corrective and
preventative actions facility wide. Track, trend, and design effective plans to
reduce Nonconforming Events, and Quality Incident reports. Ensure all facility
staff operate within federal guidelines, as well as stay compliant with all
regulatory agencies.
Accomplishments: Reduced the facility error rate by 39.7% as well as the Quality Incident
rate by 20% from 2007 to 2008. In addition reduced the facility Risk Rating by 49% from
2007 to 2008, while holding the facility at 4% under budget.
Class 100 Lead, Pharmaceutical Solutions
Ensure compliance with all cGMP standards, product documentation,
specifications, SOPs, and FDA/EMEA requirements. Operate and maintain
Inova and Bosh & Stroble sterile filling machines. Design & execute client
specific batch records, SOP s, & experimental filling operations. Lead operator
for client testing projects and validations. Operate and complete interventions in
a class 100/10,000 clean room environment in a complete aseptic manner.
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