Quality Assurance Manufacturing
Resume:
AGNES M. VUOLO
** ******* **** ****, ******, New York 10970
(C) 914-***-**** . ****@***.***
SUMMARY
A highly efficient and methodical pharmaceutical quality assurance and
compliance specialist with extensive experience in auditing laboratory,
manufacturing, packaging, and labeling documentation. Adept at ensuring
cGMPs are followed appropriately. Professional, strong collaborator, and
service-oriented with excellent industrial and interpersonal skills.
PROFESSIONAL EXPERIENCE
GLATT AIR TECHNIQUES, INC. Ramsey, NJ
Premier innovator and provider of advanced solid dosage process
technologies, equipment and services for drug development and production.
Quality Assurance Specialist 2006 to June 2013
. Expertly ensured Contract Manufacturing and Development projects were
manufactured in compliance with FDA regulatory standards and cGMPs:
o Reviewed and wrote investigation/deviation reports for Contract
Manufacturing and Development. Monitored the status of all
investigations/deviations to ensure completion in a timely manner, and
to meet requirements of SOPs.
o Initiated a CAPA if required as a follow-up to an investigation and
tracked CAPA to completion.
o Inspected and promoted compliance to in-production suites and
warehouse facilities.
o As part of a team, released raw materials based on customer
requirements including: preparation of paperwork for sampling,
distribution of samples to QC/Analytical for testing, review of test
results to ensure that they meet specifications and final release of
materials for use in manufacturing.
o Issued manufacturing batch records, packaging batch records, and
labels specific to customer requirements. On completion of
manufacturing, audited batch records for compliance to cGMPs.
o Conducted bi-monthly internal audits of QC/Analytical laboratory.
o Collaborated on external laboratory audits of vendors for cGMP
compliance.
o Issued Analytical Test Method numbers.
o Distributed approved Test Monograph to QC/Analytical laboratory.
o Wrote, revised and reviewed SOP's as required.
o Issued Protocol and Report numbers as requested for internal or
customer projects.
P.F. LABORATORIES Totowa, NJ
Prominent manufacturing facility for Purdue Pharma L.P., the industry
leader in pain management medication.
Quality Assurance Specialist II, Batch Disposition 2004 - 2005
. Proficiently performed detailed review of raw materials, packaging
components and drug product batch documentation for commercial
distribution.
o Ensured that documentation was maintained in accordance with
internal procedures and regulatory requirements.
o Performed detailed review of Quality Control laboratory tests and
Quality Assurance inspection reports to recommend approval/rejection
of raw materials, packaging commodities and labeling materials for use
in production.
o Reviewed manufacturing records of bulk, intermediate and finished drug
products for cGMP compliance and commercial distribution.
o Prepared and reviewed Certificate of Analysis
PURDUE PHARMA L.P. Ardsley, NY
Industry leader specializing in pharmaceuticals, drug development and pain
management.
Quality Assurance Specialist II 1999 - 2004
. Ensured compliance with FDA, cGMP, cGCP regulatory standards for research
and development, in addition to clinical supplies.
o Managed a high volume of critical data reviews under aggressive
timelines, maintaining an on-time delivery rate of 100%.
o Reviewed/released manufacturing/packaging/labeling documentation for
clinical trials.
o Conducted line clearance for all packaging and labeling activities of
the Clinical Packaging Department as the QA liaison. In addition,
reviewed and approved all label specifications for the Clinical
Packaging Department.
o Designed and prepared Packaging Verification Protocols for double-
blind clinical trials. Identified packaging issue for double-blind
study, prior to shipment to clinics, that required repackaging of
clinical materials.
o Member of an application development team for a tracking system to
maintain project status for clinical trials and investigations.
Maintained the tracking systems with current data on a weekly basis.
o Evaluated laboratory/manufacturing incidents to determine need for
investigations. Implemented tracking of incidents, scheduled
meetings/advise to complete investigations and ensured corrective
actions were completed.
o Qualified contract manufacturers as part of an auditing team for cGMP
process compliance.
o Reviewed analytical test results and released raw materials and
packaging components for processing.
WYETH (Lederle Laboratories) Pearl River, NY
Well-known manufacturer of OTC drugs Centrum and Caltrate, as well as
prescription drugs and vaccines.
Quality Assurance Specialist 1992 - 1999
. Reviewed and evaluated manufacturing records for release of Generic,
Consumer Health and Branded Product lines to ensure cGMP compliance:
o Reviewed Laboratory Test Results, Production and Packaging records.
o Interacted and collaborated with Manufacturing, Materials Management,
and Laboratory Personnel to resolve issues impeding product release.
o Evaluated laboratory/manufacturing deviations and scheduled meetings
to complete investigations prior to product release.
o Identified manufacturing problem that prevented the
release/distribution of $1MM Branded product. Worked with
manufacturing and technical support to develop a testing protocol to
ensure product was within specification despite manufacturing
deviation. Product was released on completion and approval of
protocol.
Biologist, Pharmacological Testing 1984 - 1992
. Tested and documented analytical results for release of Biological Drug
Products.
o Executed animal testing (rabbits, mice, rats, guinea pigs) of DTP
Vaccine, Cholera Vaccine, TB Tines, Diphtheria Toxin, Tetanus Toxin
for toxicity and potency assays required for commercial release of
vaccine products.
o Organized/maintained receipt, testing, and reporting of clinical trial
serum samples for Accelluar Pertussis Vaccine analysis to Management.
Reports were submitted to the FDA as part of the submission package
for FDA approval.
o Trained at Zymark Headquarters Massachusetts, in the validation,
maintenance and use of a Zymark Robotic System.
GIBRALTAR BIOLOGICAL LABORATORIES, INC Fairfield, NJ
40+year old firm with outstanding reputation in bacteriology, mycology,
virology, chemistry and in vitro toxicology.
Laboratory Technician/Microbiologist 1975 - 1984
. Conducted USP testing for clients of a small Contract Laboratory,
executing:
o USP Sterility Testing of Medical Products, Devices, Inoculated
Products and Carriers.
o USP Microbial Limits (Cosmetics, Raw Materials, Food and Water).
o Virology Testing.
o AOAC Use Dilutions Testing of household products.
o USP Preservative Challenge Testing of cosmetics and household
products.
o Cell Culture Techniques: Passage and Maintenance of Cell Lines for
research.
o Animal testing of cosmetic and household products (skin, eye, oral,
hypersensitivity).
EDUCATION
MA, BIOLOGY, MONTCLAIR STATE UNIVERSITY Montclair, NJ
Master's Thesis Research: Assay of Pertussis Vaccine Reactivity Factors by
Measurement of Paw Swelling Response, Endotoxin, Toxicity, and Histamine-
Sensitivity Factor
BA, BIOLOGY, COLLEGE OF SAINT ELIZABETH Convent Station, NJ
PUBLICATIONS
. Published research based on Master's Thesis Titled "Assay of Pertussis
Vaccine Reactivity Factors by Measurement of the Paw Swelling Response,
Endotoxin and Histamine-Sensitizing Factor", in Biologicals, 1993 21:45-
52.
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