Charles Wayne Hoyle

*** ****** ******

Monrovia, CA 91016

949-***-**** cell

ady2ds@r.postjobfree.com

Summary Statement

Examination of this resume will confirm my skills as a quality management professional dedicated to manufacturing safe products that exceeds customer specifications. I possess over five (5) years’ experience in orchestrating the development and implementation of Quality Management System (QMS) to comply with mandated FDA Quality System Requirements (QSR) for pharmaceuticals, medical devices and bioscience. I have directly participated in numerous FDA site inspections without the issuance of a non-regulatory notification (i.e. 483). I possess sound “hands on” knowledge with experience of the following CFR: 210,211,820,106,107,110 and ISO 13485.

Professional Credentials:

Quality Management Contractor

01/2016 to 04/2016 employed by a medical device company, STAAR Surgical to conduct mandatory Post Market Surveillance Med Watch ( Form FDA 3500 A).

02/2013 to 08/2013: Hired as Quality Management Contractor to prepare a

company for a independent third party audit. A “gap” audit

was conducted for company’s current compliance to regulatory requirements and non-conformances were transferred into the company’s CAPA program and resolved with proper documentation and verification

Quality Management

Prolacta Bioscience

605 E. Huntington Dr.

Monrovia, CA 91016

04/2011 to 08/2012

Routine daily monitoring of company’s Quality Management Systems to achieve consistent compliance to mandated GMP regulations CFRs 106, 107 and 110.

Scheduled yearly internal audit schemes to document GMP compliance/non-compliance.

Principal author for Standard Operating Procedures, SOP, with rigorous documented training for all applicable employees.

Authored Non-Conforming Material Report (NCMR).

Principal initiator of Corrective Action Preventive Action (CAPA) with excellent documentation.

Teamed with validation engineer in the development of a Validation Master Plan (VMP) that prioritized site equipment qualifications based upon cGMP impact,

(i.e. direct impact, indirect impact or no impact ).

Evaluated IQ, OQ, PQ executed documents for completeness with final quality authorization signature.

Investigated product complaints and issued final documentation to secured archive.

Created program and contracted with vendor “off-site” storage of all appropriate operations/quality documents.

Reviewed submitted batch file for GMP compliance with final release authority

Two direct reports: Documentation Specialist, GMP Quality Associate

Position was eliminated due to company restructure.

Quality Management

Phillips Consumer Lifestyle (formerly Westside Laboratory )

1700 A South Baker Ave. Ontario CA, 91761

10/06 to 11/09

Daily “hands on” management of manufacturing quality control to enforce Good Manufacturing Compliance (GMP) to FDA CFR parts 211, 820 and ISO 13485.

Maintained manufacturing in a state of “regulatory inspection readiness" by routinely conducting internal and supplier gap audits.

Directly participated in and successfully passed ALL on-site FDA, FDB, ISO inspections without the issuance of a "483” for regulatory non-compliance.

Directly supervised 15 Quality Control Inspectors that performed assorted tasks which included, incoming receiving inspection of raw materials per AQL and packaging components, first article, in-process and final article inspections of finished goods.

Authored/implemented Quality Control Work Instruction Manual with documented training of Quality Control Inspectors and routine GMP compliance training. Maintained proper and current documents with Document Control Department.

Initiated all NCMR with removal of product/material to designated quarantine area with weekly MRB meeting to assign final disposition.

Completely responsible for CAPA system that included initiation/assignment/resolution with all supporting documentation.

Routinely utilized statistical tools to evaluate process capability (CpK).

Calibration of plant instruments/fixtures estimated at 450.

Plant environmental temperature monitoring to ensure storage compliance for finished goods.

Daily and routine review of all pharmaceutical, (OTC products), batches to verify FDA regulatory compliance to part 211 that includes labels, raw materials, finished OTC goods reconciliation to master batch record. If "regulatory non-compliance" was found then initiated documented investigation with resolution and issued CAPA to prevent reoccurrence with all documentation attached to the appropriate batch record for archives by Document Control.

Controlled release of finished pharmaceutical, (OTC products), by placement in designated quarantine area until final approval documentation was complete with release stickers.

Routine daily meeting with manufacturing and engineering to resolve operational

issues and promoting continuous improvement.

Teamed with validation members to document and execute qualification of

in-process/CIP of formulation vessels and processing equipment qualifications.

Company was sold to Phillips Consumer Lifestyle and position was eliminated

Education:

Bachelor of Science: Biological Sciences, Chemistry minor

North Carolina State University and course work in Manufacturing Q.C. Statistics.

On-Line Study of the following: Writing qa Master Validation Plan, Risk Based Equipment Qualification, Guide to Process Validation, GMP Auditor, Good Documentation Practices, Validating Purified Water Systems, Cleaning Validation, Process Capability Indices, ANOVA Test, Gantt Project Mapping

Certifications:

HACCP certified

Safe Quality Food (SQF) certified

Six Sigma Green Belt Certified

References furnished upon request.

Prolacta BIOSCIENCE

Advancing the Science of Human Milk

September 24, 2012

To: Whom it may concern:

This serves as a letter of reference for Charles Wayne Hoyle. Wayne worked for me in the Quality Department at Prolacta Bioscience, Inc. for 17 months. He began here as Director of Quality and continued to serve in that capacity until his recent departure.

During Wayne's service with us I spent a considerable amount of time with him. I found him to be very much a team player and always easygoing. Wayne can definitely be described as a people person.

Wayne was also a hard worker and willing to take on any task that was given to him with a positive attitude.

In closing, I have no hesitation in recommending Charles Wayne Hoyle for any supervisory position in Quality Operations. I feel confident he would be an asset to your organization.

Scott Eaker,

Vice President, Quality and Regulatory Affairs

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