GRETCHEN MC AULIFFE
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Quality Professional with 19 years of quality management, supervision, regulatory compliance and
interpretation, and analytical laboratory experience within quality focused global environments.
Assurance
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Compliance
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Improvement
SUMMARY OF QUALIFICATIONS
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Established quality consultant with diverse background in auditing, quality management system
implementation and maintenance, training, corrective and preventive action, root cause analysis, management of
change, statistical process control and vendor management.
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Skilled auditor certified in numerous disciplines and standards (ISO 9001, ISO 13485, ISO 17025, IPEC, ICH,
SQF 2000, FDA Good Manufacturing Practices and Good Laboratory Practices). Audit experience includes
excipient and active pharmaceuticals, medical device, biotechnology, chemical, specialty chemical and
petrochemical manufacturing, packaging components, distributors, warehouses, and laboratories.
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Experienced technical writer. Writing projects include quality manuals, standard operating procedures for
quality, analytical, manufacturing, purchasing, maintenance, shipping & receiving departments, and Type II and
Type IV Drug Master Files.
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Laboratory professional with 18 years experience in petrochemical, chemical, and pharmaceutical analysis.
Background includes wet chemistry, HPLC, GC, ICP-MS, ICP-AES, IC, FT-IR, UV-VIS, nitrogen & sulfur
analysis, autotitration, particle size and laboratory operating systems. Educated in molecular biology techniques
such as Western blots, ELISA, SDS-PAGE, PCR.
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Regulatory specialist with expertise in excipient and bulk active pharmaceuticals. Compliance activities
encompass laboratory systems, quality assurance, documentation & records, validation (software, process &
analytical) and qualification (analytical instruments & manufacturing equipment).
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Project experience encompasses ISO 9001 and SQF quality system certification, cross-departmental document
systems, regulatory submissions, database implementations, LIMS & Trackwise® corporate wide deployments,
statistical process control programs, employee training programs, pharmaceutical complaint investigations and
stability testing programs
PRIMARY INDUSTRIES
Pharmaceutical, specialty chemical, excipient, petrochemical, semiconductor, medical device, food ingredients and
general manufacturing
EDUCATION
M. S., Biology
University of Houston, Clear Lake – Houston, TX
B.S., Biology
University of Houston – Houston, TX
CERTIFICATIONS
ASQ Certified Pharmaceutical GMP Professional (2009)
SQA Registered Quality Assurance Professional in Good Laboratory Practices RQAP-GLP (2008)
ASQ Certified HACCP Auditor (2008)
ASQ Certified Biomedical Auditor (2007)
ASQ Certified Quality Auditor (2006)
12929 Gulf Freeway | Suite 108 | Houston, TX 77034
GRETCHEN MC AULIFFE
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PROFESSIONAL EXPERIENCE
Founder & Principal Consultant, Labtopia Inc. (formerly EM2 Solutions, Inc.)
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Provide regulatory (GMP/GLP, ISO, IPEC, ICH) compliance solutions to the pharmaceutical, specialty chemical, food
ingredients, analytical and medical device communities
Execute quality assurance initiatives in auditing, gap assessments, quality management system implementation, training,
validation, QMS maintenance, vendor management, and technical writing
Develop and train in quality and regulatory topics such as root cause analysis, internal auditing, statistical process control,
GMPs, laboratory controls
Projects managed include:
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Implementation and audits of ISO 9001:2008 quality systems, includes writing manuals and SOPs,
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Multi-site implementation of SQF 2000 Level 3 food safety and quality systems & HAACP plan development
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Type II Drug Master File submission,
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Software verification and validation documentation (medical device), process validation (bulk API)
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Process and analytical equipment qualification protocols (including bulk API processes),
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Analytical method validation protocols,
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Conversion of quality management systems to Lotus Notes database,
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Management of ISO 17025 accreditation for multi-site commercial analytical laboratory,
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Audits of specialty chemicals/excipient manufacturers (IPEC/GMP), chemical manufacturers (ISO 9001), laboratories
(ISO/NELAC), medical device (ISO 13485/21 CFR Part 820)
Direct business activities in support of company operations including strategic planning and review, resource management,
company communications, and business development
Manage client projects comprised of proposal development, contract negotiations, project management, scheduling, on/off
site work, and deliverables
Quality Assurance Supervisor, ISP Technologies, Inc.
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2004-2006
Ensured plant compliance with ISO 9001:2000 and FDA cGMP regulations including 21 CFR Part 11
Coordinated regulatory & customer audits and investigated and responded to customer complaints. Served as quality &
technical liaison for pharmaceutical customers, registrars, and FDA.
Managed ISO 9001:2000 internal audit team and semi-annual Quality Systems Management Review
Directed quality vendor management program including audits of suppliers for raw materials, packaging, analytical testing,
distribution and warehousing.
Performed GMP quality functions including manufacturing batch record reviews, investigations into process deviations,
coordination of stability testing program for pharmaceutical excipients, review and approval of management of change
initiatives, pest control program and development, execution and/or review of validation (IQ/OQ/PQ) protocols
Drafted, reviewed and approved all customer complaint responses, audit nonconformances, OOS investigations and CAPAs
within Trackwise® database
Prepared quality and analytical standard operating procedures
Facilitated process troubleshooting teams using Kepner Tregoe® methods
Developed & conducted training for plant personnel on ISO 9001:2000, cGMP, and quality SOPs
QC Laboratory Supervisor, ISP Technologies, Inc.
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2006-Present
2001-2004
Responsible for all aspects of laboratory compliance with ISO 9001:2000 and USFDA cGMP program requirements
Managed twelve hourly union laboratory employees (includes hiring, scheduling, timesheets, discipline, grievance
procedures, arbitrations)
Assisted in planning $2.4 million laboratory annual operating budget and capital expenditures
12929 Gulf Freeway | Suite 108 | Houston, TX 77034
GRETCHEN MC AULIFFE
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Supported laboratory instrumentation, including installation, qualification (IQ, OQ, PQ), preventive maintenance, analytical
procedures and equipment repairs
Developed and managed training program (technical, safety, regulatory) for laboratory employees
Managed the Beckman LIMS database for finished goods, raw materials, and in-process specifications
Conducted variance and failure investigations in compliance with internal & regulatory guidelines
Coordinated stability testing program for pharmaceutical excipient products
Developed and implement continual quality improvement initiatives including SPC, turnaround time studies, and laboratory
efficiency projects.
Administered the laboratory safety program (includes duties of the Chemical Hygiene Officer, Chemical Hygiene Plan
revisions, safety meetings and inspections, and incident investigations)
QC Laboratory Analyst, ISP Technologies, Inc.
2000-2001
Petroleum Additives Analyst, Ethyl Corporation
1994-2000
ISO Documentation Intern, FMC Corporation
1992-1994
UNIVERSITY EXPERIENCE
Lecturer Quality Improvement Methods
Fall 2011-Spring 2012
University of Houston, College of Technology
Organizational Leadership and Supervision Advisory Board Member
May 2011 to Present
University of Houston, College of Technology
Lecturer Statistical Process Quality Control and Improvement
Fall 2008
University of Houston, Department of Industrial Engineering
SPECIALIZED TRAINING
LIMS Administration for SampleManager, ThermoScientific (2011)
Implementing SQF Systems – SQF Practitioners Course, H-E-B (2010)
Mastering Project Management, Villanova University (2010)
Excipient GMP Auditing (3 day course) International Pharmaceutical Excipient Auditing (2009)
Good Laboratory Practices for Pre-Clinical Testing: Compliance, QA and Audit, CfPIE (2007)
Excipient GMP Auditing (1 day course), International Pharmaceutical Excipient Auditing (2005)
ISO 9001:2000 Lead Auditor Training (RABQSA Certified), American Society for Quality (2004)
Internal Auditing, CAMP at University of Houston - Clearlake, (2004)
Training the Trainer, College of the Mainland (2003)
Leadership Training for Managers, Dale Carnegie (2003)
Introduction to Six Sigma, CAMP at University of Houston - Clearlake, (2003)
Kepner Tregoe Analytical Trouble Shooting Workshop, International Specialty Products (2003)
The Managers and Supervisors Conference, SkillPath Seminars (2003)
Applied Statistical Quality Control Seminar, Northwest Analytical, Inc. (2002)
Management Skills & Techniques for New Supervisors, American Management Association (2002)
Pharmaceutical Quality Assurance and Control, The Center for Professional Advancement (2001)
GC 6890 Troubleshooting and Preventative Maintenance, Agilent Technologies (2001)
Introduction to LabManager (LIMS), Beckman Coulter (2001)
12929 Gulf Freeway | Suite 108 | Houston, TX 77034
GRETCHEN MC AULIFFE
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Kepner Tregoe Problem Solving & Decision Making, International Specialty Products (2001)
Intro to Industrial Hygiene Instrumentation & Monitoring, International Specialty Products (2001)
HP5890 Troubleshooting and Preventative Maintenance, Hewlett Packard (1998)
PROFESSIONAL AFFILIATIONS
American Society of Quality (ASQ)
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Section Leadership Team, Houston Chapter 1405, )2008-2009)
Communications Chair, Houston Chapter 1405, (2009-2011)
Webmaster, Houston Chapter 1405, (2009-2012)
Certified Pharmaceutical GMP Professional exam development process (2009)
Society of Quality Assurance (SQA)
 Good Manufacturing Practices Specialty Section, 2007-present
 Vice-Chair, Good Manufacturing Practices Specialty Section, 2010-present
American Chemical Society (ACS)
Project Management Institute (PMI)
International Pharmaceutical Excipient Council (IPEC) – Corporate Member
EDITORIAL BOARD APPOINTMENTS
Quality Assurance Journal, 2008-2011
POSTERS & SEMINARS
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Implementing an Integrated Quality Management System. Gulf Coast Conference, October 2011
GFSI Certification: A Global Initiative for Supplying Food Ingredients. Gulf Coast Conference, October 2011
Effective Techniques to Solve Your Laboratory Nonconformances. Gulf Coast Conference, October 2010
Process Based Auditing in the Laboratory. Gulf Coast Conference, October 2010
Laboratory Controls in the GMP GLP Environment. Society of Quality Assurance Annual Meeting, San Diego, CA,
April 2009.
6. Laboratory Training Programs: A Game Plan for Success. Gulf Coast Conference, January 2009.
7. Practical Statistical Process Control for Laboratories. Gulf Coast Conference, January 2009.
8. Principles of GMPs for the FDA-Regulated Medical Industry - Good Manufacturing Practices 21 CFR Part 210 & 211.
Society of Quality Assurance Fall Training. Philadelphia, PA, September 2008.
9. Principles of GMPs for the FDA-Regulated Medical Industry - Good Manufacturing Practices 21 CFR Part 210 & 211.
Society of Quality Assurance Annual Meeting, Memphis, TN, April 2008.
10. Integrating ISO 17025 in a GLP Environment. Poster presented at the Society of Quality Assurance Annual Meeting,
Memphis, TN, April 2008.
11. Ensuring Suppliers and Subcontractors Meet Specifications. Society of Quality Assurance Annual Meeting, Memphis,
TN, April 2008.
12. Quality Systems in an Analytical Environment. Gulf Coast Conference, October 2007.
12929 Gulf Freeway | Suite 108 | Houston, TX 77034