Quality Control Manager
Resume:
DAVID A. AGOSTINELLI
Lock Haven, Pennsylvania 17745
*******@***.***
SUMMARY
Proven quality control laboratory supervisor/manager with 28 years of total
experience in the laboratory, 15 years in supervisory/management roles,
including experience working in the pharmaceutical industry and for ISO-
certified companies. Effective in troubleshooting and resolving quality
control issues. Demonstrated ability to lead diversified teams.
EMPLOYMENT HISTORY
> 2007- 2013 MPI Research, Inc.
State College, Pennsylvania
2008 - 2013 Manager, Quality Control
2007 - 2008 Senior Research Chemist
o Supervised and performed the quality control review of LC-MS/MS, GC-
MS, and ICP-MS analytical data packages for FDA GLP and EPA GLP
studies.
o Maintained GLP compliance in a contract preclinical
pharmaceutical/niche environmental analytical laboratory.
o Wrote, reviewed, and approved standard operating procedures and
analytical methods.
o Reviewed and approved laboratory investigation reports.
o Served as the site Quality Assurance Officer for non-GLP environmental
analysis.
> 2003- 2007 Grace Davison Discovery Sciences (formerly Alltech
Associates, Inc.)
State College, Pennsylvania
2004 - 2007 QA/QC Supervisor
2003 - 2004 Chemist
o Supervised the quality control testing of HPLC and SPE media,
capillary GC columns, and drug, hydrocarbon, and fatty acid standards.
o Served as ISO Coordinator for the site
o Performed the quality control testing of drug, hydrocarbon, and fatty
acid standards.
> 2002 - 2003 Alpharma USPD Inc.
Baltimore, Maryland
2002 - 2003 Supervisor, QC Laboratory
o Supervised the quality control testing of raw material, finished
product, and stability samples.
o Maintained cGMP compliance in a major pharmaceutical company
analytical laboratory under FDA Consent Decree conditions.
o Wrote laboratory investigation reports.
o Reviewed and approved analytical data packets.
> 1998 - 2001 Omnicare Pharmaceutics, Inc. (formerly IBAH Pharmaceutics,
Inc.)
Fort Washington, Pennsylvania
2000 - 2001 Manager, Stability and Quality Control Testing
1998 - 2000 Supervisor, Manufacturing Support
1998 Group Leader, Manufacturing Support
o Maintained cGMP compliance in the analytical laboratory of a contract
clinical supplies manufacturer/packager.
DAVID A. AGOSTINELLI
14 Park Drive
Lock Haven, Pennsylvania 17745
*******@***.***
EMPLOYMENT HISTORY (continued)
o Managed all analytical testing in support of manufacturing and
packaging, including raw material, finished product, and stability
testing, and cleaning validations.
o Wrote and approved laboratory investigation reports.
o Wrote and approved standard operating procedures and analytical test
methods.
o Reviewed and approved analytical data packets.
o Reviewed client contracts and established analytical pricing.
o Represented the analytical department in FDA and client audits.
o Audited third-party contract laboratories for compliance and
capabilities.
> 1993 - 1998 Warner-Lambert Company (now Johnson and Johnson)
Lititz, Pennsylvania
1997 - 1998 Analyst Supervisor, Mouthwash Testing
1994 - 1997 Analyst Supervisor, Stability Testing
1994 - 1994 Analyst
1993 - 1994 Associate Analyst
o Maintained cGMP compliance in a major pharmaceutical company
analytical laboratory under partial FDA Consent Decree conditions.
o Supervised the testing of raw materials, finished products, and
stability samples for the global supply of Listerine mouthwashes.
o Supervised the testing of raw material, finished product, stability,
and complaint samples for pharmaceuticals and consumer products.
o Wrote and approved laboratory investigation reports.
o Reviewed and approved analytical data packets.
o Performed routine testing of raw materials, finished products, and
stability samples.
> 1990 - 1993 Supelco, Inc.
Bellefonte, Pennsylvania
1992 - 1993 Chemist, HPLC Research & Development
1991 - 1992 Chemist, Custom Standards
1990 - 1991 Chemist, Quality Control
o Operated custom chemical standard segment of business, including
costing and pricing, devising manufacturing and testing procedures,
and providing technical information to customers.
o Standardized testing procedures for chemical standards, and
coordinated the computerization of those procedures.
o Performed routine testing of environmental standards and
chromatographic supplies.
EDUCATION
o Received Bachelor of Arts degree in Biology with a minor in Chemistry
from the University of Delaware in 1985.
o Graduated from Williamsport Area High School in Williamsport,
Pennsylvania, in 1979.
o Certified as a Lean Six Sigma Green Belt.
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