Rebecca D. Hunsinger abgh5a@r.postjobfree.com

** ***** **** *: 908-***-****

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.

Contact this candidate