Systems Providing Targeted
Remediation & 732-657-7513
DONNA M. CORDASCO - PROFESSIONAL HISTORY
QUALITY SCORES LLP
Managing Partner (Dec 2008 to present)
Co-founder and managing partner of Quality Scores LLP, a firm providing technical advisory and
QA/QC management consulting services to the pharmaceutical industry
25+ years of pharmaceutical industry experience with expertise in Quality Control /Quality
Assurance and Analytical Development; GMP Compliance/ Auditing / Remediation and the
development of Quality Systems.
Certified Lean Six Sigma Master Blackbelt with expertise in Lean/ Six Sigma training and
implementation; Problem Solving/Root Cause Analysis; Streamlining Processes; Strategic/ Tactical
Planning and Project Management
SUN PHARMACEUTICAL INDUSTRIES INC., Cranbury, New Jersey
Director of Quality Control (Feb 2007-Jan 2009)
Responsible for QC and Analytical Development staff of 30. Member of Leadership Team reporting
directly to Executive Director of SUN’s US operations.
cGMP compliance – ensured that all laboratory systems meet current industry standards.
Upgraded the laboratory equipment qualification/calibration program; re-vamped the laboratory
SOPs, instituted procedures for electronic data review; initiated a reference standard qualification
program; implemented a comprehensive training program and developed a training manual.
Productivity - Established an efficient and effective QC organization.
QC’s responsibilities included: analytical support of formulation development; development and
validation of analytical methods; preparation of ANDA documentation and technical responses to
deficiencies; preparation of methods and specifications; QC release and stability testing
Cost Savings – significantly reduced outsourcing costs by identifying opportunities to bring testing
Results: Successfully managed transition from a start-up facility to an approved commercial site. FDA
inspection (general GMP and PAI) resulted in compliance approval recommendations for all pending
products and no 483 observations. Nine ANDAs were submitted with approvals received for seven
ANDAs and the first commercial products launched.
ACTAVIS LLC, Elizabeth, New Jersey
(Note: the site was acquired by Actavis in 2005 - previously owned by Alpharma)
Director of Quality Control and Process Improvements (Sep 2006 to Feb 2007)
Responsible for QC process improvement initiatives for Actavis US sites. Reported to corporate VP of
Evaluated compliance gaps and implemented remediation activities for the Little Falls facility
Developed an implemented a program to eliminate blend testing based upon statistical analysis of
ALPHARMA, Elizabeth, New Jersey
(Note: the site was acquired by Alpharma in 2001 - previously owned by Faulding)
Master Black belt / Black belt (April 2004 to September 2006)
Deployed in a process improvement role as a Lean Six Sigma Blackbelt (Six Sigma is a statistically
based approach to reducing defects and minimizing inefficiencies). Selected for the role of Master
Blackbelt after an international selection process and a highly competitive training program. Completed
projects valued at more than 1 million dollars in savings to the bottom line. Highlights are as follows:
Deviation Management System – changes to the deviation management system resulted in a 60%
reduction in backlog and a 50% improvement in turn-around time.
Method Transfer Process– set-up receiving lab and developed streamlined processes for site-to-site
transfer of analytical testing for 19 products.
Cycle time improvement in QC raw material testing – reduced average testing time from 15 days to 7
Developed Lean Six Sigma training materials. Trained and mentored blackbelts and greenbelts on
transactional projects, defect analysis projects, leaning projects and system design projects.
Director, Quality Control (Sep 2002 to April 2004)
Accountable for a QC staff of 90 in Elizabeth and for a start-up facility in Piscataway
cGMP compliance- Represented the company during FDA inspections. Upgraded the quality of
laboratory investigations. Improved the equipment qualification program and ensured that current
industry standards were met. Refocused the QC laboratory on the fundamentals of quality and
Training and staff development – Significantly upgraded technical skills and supervisory skills in
QC. Implemented a training program for supervisors and established a skill profile for assessing QC
chemists. Developed an in-house training program to upgrade the HPLC skills of the QC staff.
Productivity – Reorganized the workflow, developed productivity metrics, and transitioned the
laboratory from an integrator based data acquisition to a modern data acquisition system
FAULDING (PUREPAC), Elizabeth, New Jersey
Director, Analytical Services (1999 to 2002)
Administrative responsibility for a fast-paced Analytical Development laboratory. Managed four
scientific groups (Specialist Teams).
Resource management and prioritization- ensured that resources were properly applied to projects so
that ANDA submission deadlines were achieved
Technical leadership- guided staff in the resolution of technical problems. Authorized technical
reports, such as validation reports, investigation reports and stability reports.
cGMP compliance- developed and administered compliance oriented programs.
Training and staff development –Coached and mentored scientific and supervisory staff to succeed in
a team-based organization.
Project Manager (1997 to 1998)
Participated in the design and development of Project Management (PM) systems. Managed multiple
projects from the development stage to product launch
Developed standardized project templates; analyzed resource requirements and development costs;
prepared status reports for Sr. Management
Evaluated opportunities to work with business partners in the development of new products
Manager, Analytical Development (1994 to 1997, 1998 to 1999)
Responsible for support of formulation development, method development, raw material testing and
stability testing for new products.
Approved documentation for ANDA Submissions - stability reports, COAs, technical reports and
validation reports. Represented Analytical Development (AD) during Pre-Approval Inspections
Project team member for the transfer of an international project. Planned and managed laboratory
activities resulting in a successful, on-time NDA submission, product approval and launch.
Supervisor, Analytical Development (1991 to 1994)
Chemist, Analytical Development (1990 to 1991)
(Part-time employment while parenting full-time)
Brookdale Community College, Lincroft, New Jersey (1990)
Lecturer- General Chemistry
Monmouth University, West Long Branch, New Jersey (1984-1988)
Adjunct Professor - General Chemistry, Organic Chemistry and Biochemistry
Trenton State College, Extension Campus in Asbury Park, New Jersey (1985)
Lecturer- Organic Chemistry for Nursing students
VETERANS ADMINISTRATION MEDICAL CENTER, New York, NY (1981-1983)
Research scientist (biochemical basis of Schizophrenia, alcoholism and senility). Responsibilities
included design of experiments, method development, technical writing and budget management.
Published 8 articles in peer reviewed journals
NEW YORK UNIVERSITY MEDICAL CENTER, New York, NY (1976-1981)
Research scientist (biochemical/behavioral experiments on the role of Dopamine in memory and
learning). Developed methods to analyze prostaglandins in blood and tissue samples
Published 4 articles in peer-reviewed journals.
TEMPLE UNIVERSITY, Philadelphia PA
Currently enrolled in graduate studies in the school of pharmacy (QA and Regulatory Affairs
NEW YORK UNIVERSITY, New York, New York
M.S. Biochemistry/Molecular Biology
(Held full-time scientist’s position while earning degree)
UNIVERSITY OF NEW HAMPSHIRE, Durham, New Hampshire
Master Blackbelt -Lean Six Sigma Academy
Blackbelt - Lean Six Sigma Academy
Project Management – Kepner Tregoe
Reduced PGE1 Stimulated 3H-cAMP Accumulation in Platelets from Schizophrenics. John Rotrosen,
Arthur D. Miller, Donna Mandio, Louis J. Traficante, and Samuel Gershon, Life Sciences 23: 1989-1996
Reduced Response to PGE1 in Schizophrenia. John Rotrosen, Arthur D. Miller, Donna Mandio, Louis J.
Traficante, and Samuel Gershon, IRCS Medical Science 6: 281 (1978)
Ethanol and Prostaglandin E1: Biochemical and Behavioral Interactions. John Rotrosen, Donna Mandio,
David Segarnick, Louis J. Traficante, and Samuel Gershon, Life Sciences 26: 1867-1876 (1980)
Prostaglandins, Platelets, and Schizophrenia. John Rotrosen, Arthur D. Miller, Donna Mandio, Louis J.
Traficante, and Samuel Gershon, Archives of General Psychiatry 37: 1047-1054 (1980)
Human Platelet Phospholipid Methylation. Donna Mandio Cordasco, David J. Segarnick, and John
Rotrosen, Life Sciences 29: 2299-2309 (1981)
Biochemical and Behavioral Interactions Between Prostaglandin E1 and Alcohol. David J. Segarnick,
Donna Mandio Cordasco, and John Rotrosen. In: Clinical Uses of Essential Fatty Acids (D. Horribin
ed.) Eden Press Montreal, Canada 1982
Phospholipids and Phospholipid Methylation in Platelets and Brain. Donna Mandio Cordasco, David
Wazer, David J. Segarnick, Andrew Lautin, Arnold Lippa, and John Rotrosen, Psychopharmacology 18:
Piracetam Reduces Alcohol Withdrawal in Mice Without Potentiating Alcohol Sedative Effects.
Michael Serby, David Segarnick, Donna Mandio Cordasco, and John Rotrosen, Alcoholism: Clinical
and Experimental Research 6: 520-522 (1982)
Red Cell Phospholipids in Schizophrenia. Andrew Lautin, Donna Mandio Cordasco, David J. Segarnick,
Lawrence Wood, Michael F. Mason, Adam Wolkin, and John Rotrosen, Life Sciences 32: 2535-2544
Norepinephrine Stimulation of Phospholipid Methylation in Rat Cortical Synaptosomes: Fact or
Artifact? David E. Wazer, Donna Mandio Cordasco, David J. Segarnick, Arnold S. Lippa, Laurence R.
Meyerson, Don Benson, and John Rotrosen, Life Sciences 32: 2535-2544 (1982)
Prostanoid Modulation (Mediation?) of Certain Behavioral Effects of Ethanol. David J. Segarnick,
Donna Mandio Cordasco, and John Rotrosen, Pharmacology, Biochemistry, and Behavior 23: 71-75
Gamma-Linoleic Acid Inhibits the Development of the Ethanol-Induced Fatty Liver. David J. Segarnick,
Donna Mandio Cordasco, Vivian Agura, Norman S. Cooper, and John Rotrosen, Prostaglandins,
Leukotrienes, and Medicine 17: 277-282 (1985)
Donna Mandio Cordasco Publications