Quality Assurance Control

Joy L. McElroy

(T) 252-***-**** (E) ***@************************.***

Professional Profile

? Twenty years experience in a GMP manufacturing environment with focus

on Validation, Quality Assurance, and Quality Control and Compliance

Auditing

? Expertise in 21 CFR part 210 and 211

? Expertise in 21 CFR part 11

? Expertise in 21 CFR part 820

? Expertise in developing and generating IQ, OQ, PQ protocols for

equipment qualifications

? Quality Control Microbiologist and Supervisor prior to Validation

career

. Validation and Quality Engineer

? Quality Auditor prior to Validation career

? Compliance Inspector for Consent Decree Projects

? Compliance inspector for Automation and Software systems

? Expertise reviewing and approving Commissioning, Installation,

Qualification, and Design documents, and Validation Protocols and

Reports, such as IQ/OQ/PQs.

? Perform failure investigations for non-conformances, perform root-

cause and gap analysis and provide recommendations to management.

? Experience in Aseptic filling and processing

? Sterilization Experience

? Lead investigator for non compliances, and OOS occurrences and

exceptions

? Ensured regular and effective communication of project status to

management.

Autoclaves (Steam Air Mix, Saturated Steam) Depyro Ovens

Automation Systems (Bradely, Delta V, DCS)

Washers Lypohalizers Depyro Ovens

Labelers Utility Systems

Fillers Transfer Pumps

Column packing systems Biowaste Systems

Controlled Temperature Units (-20, -30 and -40 C freezers and 2-8 C

refrigerators)

Education

North Carolina State University, BS Zoology Raleigh, NC

East Carolina University, Teaching Licsenure Greenville, NC

Relevant Experience

Project Development

. Development of Validation Master plans and timelines

. Development of Validation Protocols

. Development of improved filling and cleaning process

protocols

Project management

. Planned, generated, and executed Installation

qualifications, Operational qualifications, and Process

qualifications (IQs, OQs, PQs) for manufacturing equipment

. Ensured regular and effective communication of project

status to management.

. Provided full provision of technical support to system

owners during the execution of all IQ, OQ, and PQ

protocols.

. Ensured precise and well-timed completion of all

validations and ensured qualifications were consistent with

company quality standards, procedures, and policies

. Lead process and cleaning validations

. Resolved all testing incidents and deviations or

nonconformities, and OOS occurrences

Process Improvement

. Created new more efficient syringe filling and washing

processes

. Assessed organizational and employee training needs in

process validation, cleaning validation, and GMPs

. Conducted annual reviews of equipment and utility systems

. Performed gap analysis for computer systems such as

Bradely, Deltas V, and DCS

. Developed and provided GMP and technical training to

employees

. Evaluate and Implement CAPAs

Documentation

. Generated IQs, OQs, and PQs for equipment qualification

. Generated all qualification final reports

. Conducted peer reviews of validation protocols and reports

. Wrote and reviewed Engineering studies

. Reviewed documented sampling and testing results

. Wrote and revised SOPs

Computer Proficiency

. Proficient in Microsoft Suite, Word, Excel, Access, Power

Point, and Outlook

. Kaye Validator Report Wizard

. Track Wise Systems

Work Experience

Maynard Consulting Company Fayetteville, NC March 2013 -

present

Principal Consultant - contracted to Novartis Vaccines and

Diagnostics in Holly Springs, NC

July 2013 - December 2013

. ? Review audit reports for accuracy and completeness from

consultant auditors

. ? Write CAPA Plans for audited companies

. ? Determine if observations classifications are adequate

? Determine if corrective actions implemented are accurate to meet

Novartis and FDA standards

? Determine if corrective actions are GMP compliant

? Meet with international compliance team biweekly

? Schedule and coordinate international audits

? Write work orders from consultant auditors

? Enter audit reports into AQWA, a Trackwise System

Principle Consultant - contracted to BioMerieux in Durham, NC

April 2013 - May 2013

. Audited CAPAs for ETOPs for GMP compliance

. Implemented CAPAs through change control documentation, and SOP

revision

Oxford Global Resources Fort Worth, TX

December 2012 - March 2013

Independent Consultant - Contracted to Parexel International

Consulting at Ben Venue Laboratories in Cleveland, OH

? Review and audit Calibration, Preventative Maintenance,

Qualification, and Process SOPs

? Inspected and reviewed Equipment and software design

documentation

? Inspected current validation and qualification state of

equipment to determine if cGMP compliant

. Implemented CAPAs for Engineering Turnover Packages to meet

Regulatory and Compliance requirements for equipment and

automation design and function

. Audited and reviewed SAT and FAT tests for cGMP requirements

? Perform GMP compliance audits of all manufacturing areas

? Performed 21 CFR part 11 compliance inspections of the software

and automation systems used in Preventative Maintenance,

Calibrations and manufacturing equipment

? Performed security system inspections of software systems for

Preventative maintenance and calibrations and equipment

? Generate Inspection protocols and Inspection reports for

Calibrations, Preventative Maintenance, Equipment

Qualifications, Equipment design, and SAT and FAT testing

? Work directly with management and supervisors to remediate and

correct deficiencies in manufacturing and improve quality

Joule Engineering Edison, NJ April -

October 2012

Senior Engineer - Contracted to Merck Pharmaceuticals in Durham, NC

. Worked directly with departmental managers and supervisors to

achieve successful equipment qualifications

. Planned and executed Operational Qualifications (OQs) on CTUs,

incubators (32 C), refrigerators (2-8 C),

freezers ( -20, -30, -40 C)

. Calibrated equipment to be used in the execution of OQs, and PQs

. Analyzed validation protocols and SOPs for appropriate content.

. Reviewed and provided comments on the adequacy of qualification

protocols and SOPs and took the necessary steps to cure any

deficiencies

. Generated all qualification final reports

Charlotte-Mecklenburg Schools - 6th and 7th grade Science teacher - Reid

Park Academy 2011 - 2012

Sallei B. Howard School - 7th and 8th grade Science teacher in Wilson, NC

2010 - 2011

Johnston County Schools - 7th and 8th grade Science teacher - Selma Middle

School 2006 - 2010

Johnston County School - Substitute teacher

2005 - 2006

Day and Zimmerman Philadelphia, PA January

- June 2005

Validation Specialist II - Contracted to Wyeth Vaccines in Sanford, NC

. Worked directly with departmental managers and supervisors to

achieve successful equipment and process qualifications

. Generated and executed Installation Qualifications (IQs),

Operational Qualifications (OQs), and Process Qualifications

(PQs) for utility systems such as nitrogen and compressed air,

LAF systems, GMP autoclaves, biowaste systems, process cans for

manufacturing, 3000L manufacturing vessels, transfer pumps, and

column packing systems, and automation systems

. Generated final reports for all qualifications

. Researched and updated all required materials needed for

equipment and process qualifications

. Performed initial assessment and analysis to begin the

qualification process.

. Performed validations on automation systems associated with

manufacturing equipment

. Prepared and analyzed validation protocols and SOPs for

appropriate content.

. Reviewed and provided comments on the adequacy of qualification

protocols and SOPs and took the necessary steps to cure any

deficiencies

Flour Corporation Raleigh, NC February

- November 2004

Quality Assurance Engineer - Contracted to DSM Pharmaceuticals in

Greenville, NC

. Reviewed and provided comments on the adequacy of batch

production records, filling, manufacturing, and packing work

orders and took necessary steps to cure any deficiencies.

Effectively controlled the release of batch production records,

environmental monitoring, media fill, and growth promotion data.

Monitored multiple databases to keep track of all product

testing data. Successfully led GMP audits of the manufacturing

and production areas.

Mallinckrodt/ Tyco Healthcare Raleigh, NC November

2000 - February 2004

Validation Specialist

. Generaqted and executed protocols for IQs, OQs, and PQs for

utility systems, software systems, automation systems,

inventory systems, incubators, refrigerators, and

manufacturing equipment such as washers, fill machines,

labelers, and GMP autoclaves.

. Generated final reports for all qualifications

. Developed new processes for syringe filling and washing

. Developed and revised Standard Operating Procedures to comply

with current equipment and process qualifications

. Worked directly with engineers, managers and supervisors to

effectively plan and execute equipment and process

validations.

. Performed assessment and analysis of companywide Validation

Master Plan to successfully implement necessary changes.

. Developed and executed protocols for cleaning validation of

production tanks, transfer lines, and fill machine.

. Responsible for aiding in the new creative design for the

processing of various size syringe components.

Southern Testing Wilson, NC April 1999 -

September 2000

Quality Assurance Manager

. Effectively Supervised Quality Assurance personnel.

. Planned and executed new employee orientation, quarterly GMP

and GLP training to employees.

. Successfully led document control activities.

. Worked with company director and area managers to implement

validation programs for GMP laboratory equipment.

. Performed audits of the pharmaceutical, HPLC, GC,

Environmental and Agrochemical Laboratories

. Accurately respond to regulatory agency and client audit

observant

Wyeth- Lederle Vaccines Sanford, NC

Quality Assurance Specialist July 1998 - March 1999

. Reviewed and provided comments on the adequacy of batch

production records, filling, manufacturing, and packing work

orders and took necessary steps to cure any deficiencies

. Effectively controlled the release of batch production

records

. Successfully led GMP audits of the manufacturing and

production areas.

. Accurately respond to regulatory agency and client audit

observations

Abbott Laboratories Rocky Mount, NC December 1997

- July 1998

Quality Control Supervisor

. Supervised Quality Control personnel

. Successfully led document control activities

. Effectively reviewed and approved media fill and growth

promotion data

. Lucratively lead investigations for over action level

occurrences, non compliances, OOS, and media run failures

. Wrote and revise SOPs

. Accurately lead monthly staff meeting

. Determine departmental budget

. Assist in validation projects

. Conduct employee performance reviews

. Organized and coordinated personnel work schedules

_ Pharmacia and Upjohn Inc. Clayton, NC August

1991 - November1997

Quality Assurance Microbiologist

. Performed environmental monitoring of manufacturing areas

. Effectively conducted raw material bioburden testing, ambient

and thermal resistance testing, sterility testing, media

preparation, LAL water testing

. Approve media batch records and autoclave cycles

. Conducted plant wide GMP audits

. Wrote and revised SOPs

Professional Training

Technical Report Writing Supervisory Training

Laboratory Safety Training Supervising Difficult

Employees

Aspects of Coaching Lean Manufacturing

Diversity Training Six Sigma

Project Management Training

ReferencesUpon request

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