Quality Control Medical
Resume:
Rebecca D. Hunsinger *********@*****.***
Columbia, NJ 07832 C: 201-***-****
Results-driven pharmaceutical/healthcare professional
Diversified technical experience and demonstrated strengths in regulatory
affairs, quality control and assurance method validation and implementation
within a Pharmacy environment, preclinical data management, drug safety,
toxicology, and project management.
CrEdentials
DELAWARE VALLEY COLLEGE Doylestown, PA
Bachelor of Science
Major: Large Animal Science
CDM INSTITUTE Phillipsburg, NJ (2012)
Medical Administrator Program
CMAA and CBCS certification
MEMBERSHIPS
American Association of Laboratory Animal Science (AALAS)
National and State Branches
Site Safety Committee member
Girl Scout USA
SKILLS
Microsoft (Word and Excel)
Citrix System: RDSS - DrugBase module
Xybion -Pharmacy Inventory module
Medical Terminology
Anatomy and Physiology
Medical Law and Ethics
MedDRA coding dictionary
ICD-9 and CPT-4 coding
PROFESSIONAL EXPERIENCE
Merck Research LaboratorY Summit, NJ 2010 - 2011
Pharmacy Services-Formulations
Performed and verified drug calculations and coordinated scheduling with
toxicology staff. Interacted with compound director and study directors to
provide needs for studies. Performed internal audit of compound
accountability and use on study. Researched material safety and handling
procedures and ensured distribution to toxicology staff. Performed
instrument, operational and performance qualifications for all Pharmacy
workstations in preparation for UAT testing of pharmacy data system.
. Prepared test batches and submitted samples for analysis. Achieved
personal objectives while meeting departmental standards of
performance.
. Worked directly with project coordinators, clinical supply and
discovery compound group to coordinate study requirements and shipment
details.
. Supported inspection preparedness activities as per company SOPs.
Conducted daily and end of study notebook review. Assisted with the
QA audit at study completion. Answered audit questions and completed
audit report in timely manner. Conducted thorough review of study
notebook at study completion while meeting archival requirements and
deadlines.
. Knowledge of drug safety database and electronic laboratory notebook
(ELN).
. Conducted studies with test article from discovery through pre-
clinical phase as per GLP and study protocol/amendments. Collected,
verified and tabulated data using company mainframe.
SCHERING-PLOUGH RESEARCH INSTITUTE 1996- 2010
Pharmacy Services - Inventory
Responsible for shipment of analytical samples of dose preparations,
analysis receipt, recording and distribution of results to pertinent
toxicology. Maintained recertification specifications for test article used
internally and at external contract research facilities. Maintained all
pharmacy equipment and supplies. Created and maintained an on-line resource
for test and control article information. Assisted with the annual
Controlled Substance inventory audits in compliance with FDA and USDA
regulations.
. Established an analytical sample inventory logbook incorporating all
of the analytical life cycle information.
. Initiated a formal test article recertification request process.
Established internal contacts for every test article received.
. Initiated an internal maintenance plan for all Pharmacy equipment.
Maintained a current inventory of all supplies, including ordering
information, price quotes and company contacts. Maintained a yearly
calendar of all equipment maintenance schedules. Prepared a
departmental equipment list providing all pertinent details of the
equipment and location.
. Created an on-line resource for all test article information including
certificate of analysis, MSDS, stability and homogeneity data and
formulation instructions. Access to this information was obtainable
site-wide and was a strong asset of the Pharmacy.
General Toxicology
1996
Performed basic laboratory procedures for preclinical studies in common
laboratory animal species. All procedures were conducted in strict
compliance with protocols, SOP's and GLP's. Performed basic laboratory
procedures for preclinical studies in common laboratory animal species
(rat, mouse, dog, monkey and rabbit) including test article preparation,
dose administration and blood collection techniques. Performed clinical
observations associated with study design. Experienced in identification,
reporting and tabulation of adverse study findings. Recorded body weights,
food consumption, rectal temperatures, blood pressures, ECG's and
respiration. Collected blood and urine samples for analysis. Ensured all
methods are in strict compliance with protocols, SOP's and GLP's. Prepared
study notebooks and maintain detailed and accurate records. Collected,
verified and tabulated data using applicable computer systems. Prepared
study documentation for archives. Maintained laboratory equipment and
supplies.
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