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ADRIAN SCHENCK

P.O. Box 535, Somerville NJ 08876 908-619-5415 as7b88a8@westpos


t.net
Education & Training

Richard Stockton College of New Jersey B.S. Science, Major in Biology 1999
Aveta Business Solutions Six Sigma Green Belt Training
Six Sigma Lean/DFSS Training
Relevant Skills

X Demonstrated knowledge of FDA and USP regulatory requirements.


X Hands on application of ISO Standards including ISO 14644, USP NF-30, EMEA, an
d GMP/GLP regulations.
X Above average skills in Word, Excel, PowerPoint, and LIMS.
X Persuasive influencer/Collaborative/Pleasantly persistent
X Politically astute & professional
Professional Experience

LabCorp-CRO, Process Improvement Coordinator, Ewing, NJ 8/2009-present


X Assess and deploy the organizations global quality improvement initiatives in
accordance with the mission and strategic goals of the organization and GLP regu
lations.
X Collaborate with Quality Assurance and Operations Management in the creation o
f process improvement plans that identify problem areas and define paths forward
.
X Design and implement GLP compliance and departmental cross-training programs f
or new and existing employees.
X Interface with clients to ensure that all mechanisms required for the developm
ent and validation of sample analysis for therapeutic proteins are established.
Roche Molecular Systems, Principle Scientist, Branchburg, NJ/Rotkreuz, Sz 1/200
4-2009
Environmental Monitoring-Quality Control Microbiology (medical device)
X Performed environmental monitoring data trend analysis, OOS investigations, de
termined root-causes, and implemented corrective and preventative actions where
appropriate.
X Led and executed environmental monitoring and process validation activities fo
r regulated medical device facilities, including HVAC, clean steam, and high pur
ity water system validations, for a 188,000 square foot facility containing ISO
Class 5, 7,8 (A, C, D) manufacturing areas.
X Coordinated and documented the shutdown and approved or re-evaluated the start
up of HVAC and high purity water systems.
X Designed all validation studies for, and led the execution of procedures relat
ed to the consolidation of two quality control microbiology laboratories into on
e location to reduce headcount and cost of testing. (Including but not limited t
o sample/specimen transport, water temperature hold time, and method transfers).
X Coordinated and executed all sterile and non-sterile gowning verification trai
ning and testing for three ISO Classes 5, 7, (A, C, D) regulated facilities.
X Designed classroom training, self study curriculum, and bi-annual competency t
raining for the execution of quality control laboratory testing and environmenta
l monitoring procedures.
X Validated USP harmonized microbiological test methods including bioburden test
ing and microbial enumeration, to support product release
X Validated the following instruments and software programs to replace in-use in
struments. The addition of these instruments drastically reduced turn-around ti
me and overall use cost.
Biolog Microlog 1.0 Identification System
Biolog 4.2 Microbial Identification System
Hach Ultra Met One Model 3400 and Model 3414 Portable Laser Particle Counters (F
irmware)
Biomerieux Vitek Legacy Microbial Identification System (Data Track)
Biomerieux Vitek 2 Compact Microbial Identification System (AES)
Millipore Milliflex Pump Filtration System
Sievers Model 900 Total Organic Carbon Analyzer (Data Pro) V vendor present
New Jersey American Water, Senior Lab Technician, Bridgewater, NJ 5/2002-2004
X Analyzed raw and EPA potable water for DEP compliance in accordance with ISO g
uidelines and FDA regulations.
X Performed laboratory jar tests to determine the chemical load required to meet
regulatory standards.
X Performed total organic carbon analysis, ionic chromatography, specific gravit
y testing, pH testing, metal and sulfite extractions, titrations, and other rout
ine water testing procedures.
X Analyzed data and authored final reports to initiate the resolution of custome
r complaints.
LOreal USA, Microbiologist, Piscataway, NJ 4/2001-2002
X Identified bacterial isolates found in cosmetics and powders using compound mi
croscopy and API 20E Strip ID system.
X Performed routine sanitization validations and data trend analysis on all pre-
cleaned and post-use line components.
X Provided guidance and assistance to production for the release of finished and
raw materials pending microbial content results.
X Utilized Lotus Notes to record the status of microbial count excursions for fi
nished products and raw materials.
Professional Affiliations
X Pharmaceutical Microbiology Forum
X American Society for Quality
X New Jersey Science Education Leadership Association
X American Safety and Health Institute
X International Society of Six Sigma Professionals

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