Quality Assurance Control
Resume:
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John P. Tuttle
Home address:
Acton, MA 01720
Email: ***********@*******.***
Home Phone: 978-***-****
Mobile Phone: 978-***-****
Summary:
Professional quality assurance and quality control manager with over 30 years experience
managing quality system programs for a multinational company. Proven skills in auditing
quality systems for compliance to ISO 9000 and drug/device cGMP's. Developed industry
leading programs related to process validation, change control, change management, CAPA,
and the resolution of customer complaints. Experienced in conducting and managing FDA and
customer audits. A customer focused professional who uses a practical, innovative and
analytical approach to problem solving.
Professional Experience:
REPLIGEN CORPORATION, WALTHAM, MASSACHUSETTS
Quality Systems Consultant (2010 - 2012)
Provided consulting services on Quality System projects including the development and
introduction of new Bioprocessing products.
REPLIGEN CORPORATION, WALTHAM, MASSACHUSETTS
Director of Quality (2006 - 2009)
Responsible for directing Repligen's Quality Assurance and Quality Control functions and
developing a formal quality management system.
Helped Repligen implement a Business Continuity Management System (BCMS) achieve
certification to British BCMS standard (BS25999). Repligen was the first company in North
America to receive BS25999 certification.
Developed a Quality Management System that is in compliance with ISO 9001:2000.
Identified the need for an electronic documentation system, documented the requirements
of a EDMS that would meet Repligen's needs and lead a team that evaluated available
software applications.
Developed a professional QA/QC staff capable of meeting Repligen's increased focus on
quality management and meeting customer quality expectations.
MILLIPORE CORPORATION, BEDFORD MASSACHUSETTS (1976 - December 2003
)
Manager, Quality Systems Programs (1994 - 2003)
Responsible for creating and managing Millipore's BioProcess Quality Systems Department.
Managed 12 quality professionals and the division's worldwide quality programs.
* Functioned as company quality liaison to major biopharmaceutical accounts worth over
200 million in annual sales.
* Created an industry leading customer change notification system that became a model
program for the pharmaceutical industry. Established and implemented worldwide change
notification policies and procedures
* Instrumental in restoring customer confidence in a 15 million dollar product line after
a product recall.
* Maintained Millipore's quality leadership position by obtaining ISO 9000 Quality
Management registration for the BioProcess Division. Responsible for the first
registration of a Millipore division to ISO 9001. Registration was recommended after first
initial assessment. (BioProcess Division - 1994).
Manager, Customer Certification Program (1991 - 1994)
Responsible for creating and managing a worldwide Customer Certification Program for
Millipore.
* Developed and implemented the first Customer Certification Program for a supplier to
the pharmaceutical industry. The program became a model for the industry.
* Used the Customer Certification Program to establish Millipore as a certified supplier
to three major pharmaceutical customers worth over 20 million dollars in annual sales.
Established Millipore as a quality leader in supplier certification.
Manager, Quality Assurance, Jaffrey New Hampshire Operations (1988 - 1991)
Responsible for managing the quality function for Millipore's largest manufacturing
facility. Managed a department of 30 QA/QC employees in a high technology laboratory
environment.
* Increased competency of the department by hiring quality professionals to supervise the
major quality functions. Expanded the department for 20 to 30 employees.
* Created an award wining customer audit process that demonstrated Millipore's quality
awareness to customers and became a selling tool for sales and marketing. The audit
process was designed to manage customer audits for a positive outcome and assure customer
satisfaction.
* Obtained ISO 9000 Quality Management System registration for Millipore's Jaffrey
manufacturing facility. Jaffrey was Millipore's first facility to be registered to ISO
9002 (fourth US company registered by LRQA in 1991). The Plant was recommended for
certification after the first initial assessment.
* Implemented Pharmaceutical CGMP in the Jaffrey facility to satisfy customer
expectations. Manager, Quality Control, Bedford Massachusetts Operations
(
1984 - 1988)
Responsible for managing the quality function for Millipore's Bedford manufacturing
operations. Managed a department of 20 QA/QC employees.
* Established a continuous quality improvement program for Millipore's BioProcess
Division. * Implemented a computer aided quality control system for data analysis and
management reports. * Developed requirements for manufacturing in a clean room to improve
product cleanliness and reduce customer complaints.
* Improved incoming quality control by implementation of a supplier quality program.
Manager, Quality Assurance, MPD Division (1980 - 1984)
Responsible for managing the quality assurance function for Millipore's MPD Division.
Managed a group of 4 quality professionals.
* Developed and implemented an award winning customer complaint management system
designated "A.C.E." (Acquisition of Customer Experience).
* Wrote programs to analyze complaint information and generate management reports.
* Established a process to ensure customer satisfaction with complaint resolution.
Director, Corporate Quality Engineering (1976 - 1980)
Responsible for creating and managing a quality engineering department for Millipore's
corporate headquarters. Successfully met the charter for the department which was to
establish and maintain compliance with FDA Medical Device cGMP regulations. Managed a
group of 14 quality engineering professionals.
* Developed and implemented an engineering documentation system to meet FDA cGMP
requirements.
* Established a hierarchical document management system for product descriptions, process
specifications, SOP's, test specifications, test methods, purchase specifications and
drawings.
* Developed and implemented a program for new product validation and qualification.
* Instituted Statistical Quality Control.
WORTHINGTON BIOCHEMICAL CORPORATION, FREEHOLD, NEW JERSEY (1969 - 1976)
Director, Quality Assurance & Regulatory Affairs
Established a quality assurance and regulatory affairs function to address FDA, EPA and
OSHA issues.
* Worked with FDA on New Drug Applications.
MICHIGAN STATE UNIVERSITY, EAST LANSING MICHIGAN (1967 - 1969)
Teaching Assistant
in Biochemistry
Education:
B.A. Lake Forest College
Lake Forest, Illinois
Major: Chemistry
M.S. Michigan State University
East Lansing, Michigan
Major: Biochemistry
Awards & Recognitions:
Navy Science Cruiser Award
Greater Newark Science Fair
First Place; Biological Sciences
Greater Newark Science Fair
Alumni Award For Excellence In Chemistry
Lake Forest College
Honors in Chemistry/Senior Thesis
Lake Forest College
Best Written Technical Paper
National ASQC Congress, Chicago, Illinois
Publications:
Memberships:
American Chemical Society
American Society for Quality Control
Parenteral Drug Association
International Society for Pharmaceutical Engineering
Updated: May 30, 2012
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