Quality Assurance Control
Resume:
DANIEL FINK
Fort Collins, Colorado 80528
Phone: 970-***-****
**********@*****.***
A versatile Quality Assurance (QA) Director and Manager with ASQ
certifications and experience in the regulated pharmaceutical, biotech, and
medical device industries. Specific experiences include finished dosage,
medical devices, active pharmaceutical ingredient (API), and in-vitro
diagnostic device manufacturing and development. Expertise in development,
implementation, improvement, and management of the current Good
Manufacturing Practice (cGMP), Good Laboratory Practice (GLP), and Good
Clinical Practice (GCP) related quality assurance/quality control systems
and programs. Experienced in the management of quality assurance and
validation departments. Proficient at managing multiple improvement
initiatives and projects within timeline constraints. Recognized for
initiative, adaptability, innovative thinking, and enthusiasm in working to
meet customer and FDA requirements.
EMPLOYMENT EXPERIENCE
DLF QUALITY CONSULTING, LLC, Fort Collins, Colorado 2009-Present
QA Consultant, Founder
Established DLF Quality Consulting to provide quality assurance services
that meet the needs of the pharmaceutical, biotech, and medical device
industries. Services include evaluation and development of quality
systems, quality manuals, document control systems, CAPA programs, change
control programs, validation programs, and training programs. Review and
approval of policies, procedures, master batch records, product
specifications, raw material specifications, CMC sections, validation
protocols, and reports. Performance of QA management responsibilities
including product release, supplier and vendor audits, QA oversight of
quality control laboratories, API manufacturer Q7A audits, internal and
external cGMP/GLP/GCP audits including contract manufacturer audits.
Management of projects related to the development and manufacture of
pharmaceutical, biotech, and medical device products.
Specific Client Activities performed:
. Managed Quality Assurance activities for an independent division of a
major pharmaceutical, household, health and personal care product
manufacturing company.
. Developed, approved, and implemented all Quality Assurance Systems,
consisting of policies, procedures, forms, batch records, and
specifications used for the manufacture and release of pharmaceutical
products.
. Conducted internal and external audits related to the manufacture of
pharmaceutical products.
. Released raw materials, components and finished pharmaceutical products.
. Reviewed and approved deviations, out of specification reports (OOS),
change control activities, validation protocols, and stability protocols.
. Created and executed training programs for the implementation of approved
quality systems.
PR PHARMACEUTICALS, INC., Fort Collins, Colorado 2007 - 2009
Head of Quality
Responsible for developing, implementing, and communicating the company's
quality strategy with regard to compliance with regulatory standards that
affect the company's activities in developing pharmaceutical and active
pharmaceutical ingredients products. Management of the Quality Department
in regards to all aspects of the company's quality systems, including
annual product reviews, batch record review and release, corrective and
preventive action, inspection and release of incoming materials, document
control, personnel performance reviews, and departmental budgeting.
Managed all company QC data review for final approval and release of
products and raw materials. Direct report of the company President in
regards to implementation and achievement of the company's quality goals.
Daniel Fink, Page Two
. Managed Quality Assurance Department of 4 members and their associated
activities supporting multiple manufacturing and development projects and
products.
. Managed the restructure, revalidation, and implementation of the
company's electronic data system for quality control and manufacturing
data of incoming material for release, manufactured product data review
and release, quality control data review and approval, supplier
qualification tracking, environmental data evaluation, validation
protocol management, and deviation investigation and CAPA data
management.
. Developed and implemented a simplified and maintainable material
specification system allowing research, development, and manufacturing
personnel to be the primary authors of material specifications.
. Implementation of a revised incoming material inspection system that
reduced overall inspection and release time by approximately 30%.
. Represented the company's quality assurance interests in regards to
supplier, contract manufacturing and collaborative
manufacturing/development projects, including supplier audits and
qualification.
. Responsible for the management and Quality Assurance approval of all
company controlled documents, validation protocols, and change control
activities, consisting of more than 1300 documents.
ABBOTT LABORATORIES, INC., Des Plaines, Illinois 2004 - 2007
Quality Assurance Manager, Validation
Abbott Molecular Division
Responsible for the management and leadership of the QA Validation unit
within the Abbott Molecular Division. Establishing strategic direction of
the unit to meet Abbott Molecular's long-term goals. Accountable for
establishing, implementing, and maintaining the quality system including
policies, planning, and the unit's organizational structure. Management of
the human resources for the unit consisting of 7 individuals, including
contract validation professionals, in the execution of validation plans and
protocols.
. Managed validation activities in the launch of 3 diagnostic tests
including the 3 diagnostic test kits and 2 diagnostic instruments.
. Formulated plans to provide facility, utility, equipment, process, and
test method validation for the Abbott Molecular pipeline of products in
order to meet requirements for commercialization.
. Managed validation activities for the full renovation of the new Abbott
Molecular Des Plaines, IL facility, which consolidated two groups of
approximately 175 employees each into one independent Abbott Molecular
facility and division headquarters.
. Established and directed validation review boards that focused groups of
cross-functional department heads on validation issues.
. Recipient of the 2005 Abbott Molecular President's Award for the Des
Plaines Illinois Facility Project.
ABBOTT LABORATORIES, INC., North Chicago, Illinois 2003 - 2004
Computer Validation Analyst,
Quality Operations Global Engineering Services for Global Pharmaceutical
Operations
Responsible for development and management of software validation
activities that support Abbott Laboratories' Utilities and Facilities
groups in Lake County, IL. Development, management, and execution of
software validation packages for high purity water systems and process
alarm systems for environmentally controlled areas. Member of a validation
team consisting of 8 individuals, including contract validation
professionals.
. Developed and executed software validation packages for 7 process
alarm/environmental control system installations.
. Created plans to provide software validation for 24 additional process
alarm/environmental control system installations throughout Abbott
Laboratories Lake County, IL.
. Representative for Quality Operations Global Engineering Services for
Global Pharmaceutical Operations at all Validation Review Boards.
Daniel Fink, Page Three
FERRO PFANSTIEHL LABORATORIES, INC., Waukegan, Illinois 1991 - 2003
Ferro Corporation (Formerly Pfanstiehl Laboratories, Inc.)
Senior Quality Engineer (1998 - 2003)
Responsible for the review, approval and release of batch records and
quality control testing results for manufactured materials. Responsible
for development and management of process, cleaning, and equipment
validation programs, that supports the manufacture of active pharmaceutical
ingredients (API's) and high purity excipients utilized in parenteral,
oral, and topical pharmaceutical products. Management of a validation team
consisting of 4 individuals, including contract validation professionals,
in the execution of validation plans and protocols. Management of company
wide instrument calibration program. Set-up, implementation, and
improvement of cGMP quality systems for all levels of the organization.
. Provided QA Departmental services in the release of approximately 625
lots of product annually.
. Developed and executed process validation protocols for 19 API's and high
purity excipient processes. Validation efforts have supported increase
in pharmaceutical sales from approximately $6 million (1993) to $16
million (2002).
. Coordinated design and validation of a multi-million dollar high potency
computer controlled manufacturing facility with data acquisition
capabilities. The facility has provided a superior manufacturing
environment for quality of the product and safety of the operator.
Facility, equipment, and process improvements have produced an
approximate 30% increase in an API yield, realizing an approximate
$320,000 annual cost savings.
. Formulated plans to provide process validation of 17 pipeline products in
order to meet customer timeline requirements for commercialization.
. Developed cleaning validation master plans for a multi-purpose
manufacturing facility. Plans included cleaning validation for more than
100 products utilizing product grouping techniques and 10 individual API
product plans. Product grouping (matrix) techniques were utilized to
reduce cleaning validation costs versus exclusive use of individual
product cleaning validation plans.
. Created cGMP and Q7A compliant quality systems to provide change control
for processes, documentation, systems/equipment, and suppliers.
. Participated in hosting 7 FDA and approximately 100 customer inspections
from 1993-2002 that contributed to the increase in pharmaceutical sales.
Quality Engineer (1993 - 1998)
Responsible for development and management of validation and calibration
systems. Creation and implementation of quality systems in a newly formed
Quality Assurance and Regulatory Affairs Department. Identification and
implementation of corrective action plans in all areas of the organization.
Review and approval of all types of policies, procedures, and
manufacturing documentation including release of finished goods.
. Developed validation systems to cover equipment and utility system
installation, operation, and performance qualification. Led validation
initiative and managed validation personnel such that over 275 individual
systems and equipment were qualified and remained qualified during
equipment upgrades.
. Coordinated and managed the design, installation, and validation of 2 USP
Purified Water systems.
. Established and administered a facility wide instrument calibration
program that provided more than 30% annual cost savings compared to use
of contract calibration services.
. Led supplier, contract manufacturer, and contract laboratory assessment
group, where reassessment time of suppliers was reduced by more than 25%.
. Conducted new employee cGMP training during a period of tremendous growth
where the number of employees increased by more than 75% (65 in 1993 to
115 in 1996).
Daniel Fink, Page Four
Assistant to the Scientific Director/Quality Assurance (1991 - 1993)
Responsible for direction of quality assurance related activities including
issuance of manufacturing records, drafting and approval of all types of
policies, procedures, and manufacturing documentation.
. Established and directed a Quality Assurance Committee that focused a
group of cross-functional department heads on quality related issues.
The QA Committee was recognized as being essential to Pfanstiehl's
organizational structure resulting in the establishment of the Quality
Assurance and Regulatory Affairs Department.
. Initiated an annual offsite company wide cGMP training program to promote
current Good Manufacturing Practices throughout all levels of the
company.
CARGILL INCORPORATED, Carpentersville, Illinois 1991
Quality Control Chemist
Responsible for raw material and finished goods testing and release.
Provided in-process testing support for critical manufacturing decision
points.
EDUCATION AND CERTIFICATION
UNIVERSITY OF ILLINOIS, Urbana-Champaign, Illinois
Bachelor of Science in Liberal Arts and Sciences - Chemistry Major
AMERICAN SOCIETY OF QUALITY CERTIFICATIONS
ASQ Certified Manager of Quality/Organizational Excellence - 2009
ASQ Certified Pharmaceutical GMP Professional - 2009
. ASQ Certified Pharmaceutical GMP Professional Exam Development and
Improvement Team Member - 2010
. Process Validation Requirements and Industry Practice - 2006 - AAMI
Association for the Advancement of Medical Instrumentation
. Complying with Computer and Software Validation Requirements - 2003 -
Pharmaceutical Training Institute International
. Cleaning Validation and Cleaning Processes Seminar - 2002 - Barnett
International
. ICH Q7 Good Manufacturing Practice Guidance For Active Pharmaceutical
Ingredients (APIs) Seminar - 2001 - Parenteral Drug Association (PDA) an
International Association for Pharmaceutical Science and Technology
. Check Point Validation Conference - 1998 -Institute for International
Research (IIR) Pharmaceutical Division
. Cleaning Validation Seminar - 1996 - Parenteral Drug Association (PDA) an
International Association for Pharmaceutical Science and Technology
. Bulk Pharmaceutical Chemical Process Validation Training Course - 1995 -
Pharmaceutical Education and Research Institute (PERI)
. Management of Validation Course - 1994 - International Society for
Pharmaceutical Engineers (ISPE)
. Train the Auditor Course - 1993 - The GMP Institute
. "GMP 101" The Basics of Good Manufacturing Practice Course - 1992 - The
GMP Institute
. Compliance, Enforcement, Inspections Seminar - 1992 - Regulatory Affairs
Professionals Society
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