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Quality Control Manager

Location:
Philadelphia, PA, 19152
Posted:
May 07, 2010

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Resume:

Martina Dennis

*******.******@**********.***

Work Experience:

September 2006 to Present Tandem Labs West Trenton, NJ

Associate Research Scientist - Immunoanalytical Division

Performs validation and sample analysis assays for drugs and

antibodies to drugs, from biological samples, for projects according

to prescribed procedures and practices as well as project

directives. Set up runs in Watson. Performs ELISAs and advanced

technologies (including but not limited to technologies such as:

Bioveris: MesoScale, robotics; automation;etc.) Performs routine

maintenance on instrumentation. Performs minor repairs on

instrumentation at the direction of service engineers or other

trained supervisory personnel. Documents all maintenance,

calibration, and repairs as required. May perform reviews of

analytical data for acceptability. Prepares reagents, solutions,

and QC's per procedure as needed to perform routine assignments.

Properly uses and maintains analytical equipment to accomplish work

objectives. Effectively communicates with team members and

supervisors regarding work related issues. Maintains clean,

organized work area. Performs special projects designated by

supervisor or manager. Actively participates in training sessions

related to job functions.

Nov 2004 to Aug 2006 Roche Molecular Systems, Inc Branchburg, NJ

Scientist- Quality Control

Performed DNA/RNA amplification/ detection for release and stability

testing on PCR IVD components and test kits in conjunction with the

RMS production schedule and stability program. Performed functional

testing of raw materials such as HIV, HCV, HBV, CT/NG, MTB, MAV,

CMV, and Blood Screening Products etc. Handled microorganisms such

as normal human plasma, patients sample, HIV, HCV, HBV, CT/NG, MTB,

MAV, and CMV etc. Worked daily in BL2 laboratory environments.

Performed DNA/RNA manual testing with PCR assays such as ELISA,

extractions, Poisson assays, High Pure assays, etc. Performed

DNA/RNA automated testing with Thermocycler 9600, COBAS Amplicor, GT-

12, COBAS Ampliprep, COBAS Taqman 48, and COBAS TaqMAn 96. Usage of

the Quality Laboratory Information Management System (LIMS) and

validation spreadsheets (MS Excel) for the accuracy, quality, and

timeliness of testing results. Provided assistance with method

development, execution of validation, protocols, and writing and

revision of documents (e.g., SOPs, QC specifications). Maintain

test data and document laboratory activities using the LIMS system.

Performed value assignments/range assignments. Ensure laboratory

equipment is maintained, calibrated and/or validated.

Martina Dennis

*******.******@**********.***

Mar 2004 to May 2004 Huntingdon Life Sciences, Princeton Research Center

East Millstone, NJ

Technician

Worked as a temporary employee in small mammal laboratory.

Participated in GLP training. Knowledge of clinical SOP's and

company protocols. Performed data entry and collection. Weighed

test material for development and research

Jun 2002 to Aug 2002 Brookside Veterinary Clinic Bloomfield, NJ

Veterinary Technician.

Worked as a summer intern who assisted veterinarian in handling cats,

dogs, and birds. Administered medical treatment to animals.

Provided food and exercise activities for animals.

Education:

Cook College, Rutgers University, New Brunswick, NJ

B.S., Animal Science/Pre-Veterinary Medicine and Research December 2003



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