Quality Assurance Manufacturing
Resume:
Drew Millette
Durham, NC 27703
336-***-**** ****.********.*****@*****.***
OBJECTIVE
To combine significant scientific and GLP knowledge base with pharmaceutical industry leading Quality
Assurance experience to ensure compliance at Park Hudson International Raleigh site
QUALIFICATIONS
1.5+ years of pharmaceutical experience performing Quality Assurance in cGMP pharmaceutical
manufacturing facility
3.5+ years of GLP experience working with bioanalytical methods such as Quantitative Real-
Time PCR, ELISA immunoassays, Western blotting, RNA extractions, protein extractions,
reverse transcription protocols for cDNA synthesis, mouse colony management, tissue harvest,
mammalian cell culture maintenance, viral proliferation experimentation (HSV-1, Adenovirus,
influenza, coxsackie virus), among others
Full working knowledge of FDA, EU, and international regulations
EDUCATION
University of North Carolina at Chapel Hill
M.S., Nutrition (Nutritional Biochemistry), 2012
Master’s thesis: “Short-term Feeding Effects of High-Fat Diet on Hippocampal Neuroinflammation:
Differences among C57BL/6J, C3H/HeN, and C3H/HeJ mice.”
University of North Carolina at Chapel Hill
B.S., Biology, 2009
Minor in Chemistry and Music
RELEVANT EXPERIENCE
Merck Manufacturing Division – Durham Feb 2013 – Present
Durham, NC
The Maurice R. Hilleman Center for Vaccine Manufacturing
Quality Assurance Associate Specialist (Contract) that reviews vaccine manufacturing orders in
accordance to FDA regulations, analyze Electronic Batch Record (EBR) for documentation errors
ensuring proper current good manufacturing practices (cGMPs) and safety of vaccines prior to release,
and Subject Matter Expert in Quality batch record review for several shop floor orders
Ensure efficient production control of Varivax, Zostavax, Measles, Mumps and Rubella (MMR)
vaccines, and Harvest Viral Fluid (Concentrated 2X Bulk Varicella)
Review and approve integrated batch data from automated systems (DeltaV, RtReports, PAS-X –
MES EBR, LIMS, SAP, and MIDAS)
Support Operations to resolve errors and issues pertaining to documentation and batch execution
Improve communications between Operations and Quality units through Kaizen events
Train fellow employees to complete tasks according to Merck Quality guidelines and site SOP’s
Author investigation memos/Quality Notifications that drove CAPAs for process improvement
Revise Quality department SOPs for conducting Quality batch record review and integrate error
trending as part of performance metric tracking
Thorough understanding of FDA regulations including CFR 21 part 11
Drew Millette
5480 S. Miami Blvd Apt 204
Durham, NC 27703
336-***-**** ****.********.*****@*****.***
UNC Gillings School of Global Public Health Chapel Hill, NC 2010-2012
Graduate Research Lab Technician
Conducted original research under the supervision of Dr. Patricia Sheridan in the Department of Nutrition
regarding the role of Toll-like Receptor 4 (TLR-4) in high fat diet-induced neuroinflammation.
Perform Quantitative Real-Time PCR, ELISA assays, RNA and protein extractions
Manage mouse colonies, mammalian cell cultures, and tissue harvests
Developed laboratory protocols decreasing experimental costs as well as increasing the reliability
and efficiency of data
Experienced in BSL-2 immunology/virology environment involving H1N1 influenza, Coxsackie
virus, Adenovirus, and HSV-1 as part of Melinda Beck lab (UNC-CH)
Conducted thorough literature reviews in experimental design development
Lead departmental talks on ongoing research within Sheridan/Beck lab
2008 – 2009
UNC Lineberger Comprehensive Cancer Center Chapel Hill, NC
Research Lab Technician
Researched the effect of re-expression of the SNF5 tumor suppressor gene, part of SWI/SNF chromatin
remodeling complex, on malignant rhabdoid tumor cell growth. Worked under Dr. Bernard Weissman in
the Department of Pathology and Laboratory Medicine.
Skilled in quantitative real-time PCR, Western blots, RNA extractions, protein extractions
Maintain cancer cell cultures and performed adenoviral infections for SNF5 re-expression
HONORS
Dean’s List (4 terms)
ZBT Academic Excellence and Leadership (2007)
LEADERSHIP EXPERIENCE
Founding Father of Zeta Beta Tau Chapter (UNC Alpha Pi)
Residence Hall Association Community Government (OCLQ) 2006-2007
Stacy Hall President 2005-2006
Olde Campus Lower Quad Activities Coordinator
Tae Kwan Do instructor (3rd degree Black Belt)
SKILLS
Proficient in French (intermediate level)
Experienced in current Good Manufacturing Practices (cGMPs), Good Documentation Practices
(GDP), and Good Laboratory Practices (GLPs)
Train the Trainer Certified (DTCC)
Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Access)
Proficient in utilizing MES PAS –X, SAP, RtReports, LIMS, MIDAS (documentation
repository), and GSS spreadsheets
Experienced with JMP statistical software and GraphPad Prism (data publishing software)
Contact this candidate