Quality Assurance Process Improvement
Resume:
MELISSA TOSCANO GARCIA
Mahwah, NJ 07430
*******.*******.******@*****.***
OFFERING STATEMENT
Applicant desires position as a QA Specialist requiring working knowledge
of FDA regulations, attention to detail, and exceptional organizational
abilities with respects to reviewing material, batch record, and final
product release.
WORK EXPERIENCE
Celgene Cellular Therapeutics, Warren, NJ August 2010-
Present
Sr. Clinical Production Associate December 2012-Present
Clinical Production Associate August 2010- December 2012
? Performs daily Batch Record issuance to Clinical Production members in
order to manufacture clinical grade material
? Reviews completed Batch Record procedures, equipment, and room subsidiary
maintenance forms for accuracy and completeness
?Works closely with Quality Assurance for addressing discrepancies within
production records for the release of manufactured product lots
? Composes Investigations for Non-Conformances and CAPAs in conjunction
with Quality Assurance department
?Utilization of EREXS and EQRMs for electronic document control, change
control in order to manage document revisions, and Deviations/ CAPA reports
?Continuously works towards decreasing lead time of manufactured product
release to meet clinical demand time lines
?Participation in risk assessment meetings and reviewing of FDA warning
letters in order to develop process improvement
?Composing and Implementing Batch Records and SOPs to reduce contamination
risk and allow for a more efficient and compliant process
?Member of a cross functional team tasked with developing a kSep400 closed
centrifugation process
? Daily processing of GMP grade aseptic processing in class A and B
certified Clean Room environments
? Maintained and delivered sufficient supply of appropriate grade material
for clinical studies in accordance with timelines
Lundbeck Research USA, Paramus, NJ January 2006
to June 2009
Intern in Cell Biological Sciences
? Developed more efficient ways to grow large quantities of a cell line
under extensive selection pressure to be used in a High-Through-put
screening assay project
? Performed micro-pipette injection of DNA into frog oocytes and Electro-
physiological analysis
? Carried out bacterial transformations, as well as mini-preps for plasmid
isolation and gel electrophoresis to verify presence of DNA
? Performed several transient transfections into primary mammalian cell
lines
? Cell membrane harvest and observed expression through the performance of
GTP Gamma s-35 binding assays as well as protein concentration through
Bradford Protein Assays
SKILLS
Knowledge of CFR guidelines, strong written and oral communication skills,
histological techniques, Qualified in aseptic technique, Good Documentation
Practices, GMP protocols, and contamination control
EDUCATION
Masters of Science in Regulatory Affairs For Drugs, Biologics, and Medical
Devices, Northeastern University College of Professional Studies (online),
Boston, MA (Present)
Bachelor of Science in Molecular Biology, Montclair State University,
Montclair, NJ (2010); GPA 3.713; Honors: Dean's List (Multiple Semesters)
Graduated Magna Cum Laude
Associate of Science in Biology, Bergen Community College, Paramus, NJ
May 2008; Cumulative GPA 3.95 Major GPA 4.0
Honors: Dean's List, Phi Theta Kappa, Excellence in Biology Recognition
Award, Magna Cum Laude
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