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Title : MKG- Quality Specialist - II -730
State : Pennsylvania   Date : Apr 4, 2020
Experience Level :  
Position Type : Quality Specialist - II      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: West Point, PA

Job Title: Quality Specialist - II

Duration: 12+ months (extendable) contract on W2


Duties: 

The Quality Specialist will be responsible for supporting Critical Reagent programs in a fast-paced environment within the Vaccine franchises. The support is critical to testing within the Quality Control Laboratories. This position requires experience in general cell biology and either virology or biochemistry techniques. Under the guidance of an Manager, the position requires experience in virology and biochemistry techniques including ELISA, antibody production, cell culturing, QPCR and cell line expansions. The Quality Specialist is responsible for independently managing the complete lifecycle of Critical Reagents such as; reference materials, positive controls, anti-sera and other critical materials. In addition, the Specialist will be responsible for independently managing the complete lifecycle of Critical Reagents such as; reference materials, positive controls, anti-sera and other critical materials. Release and stability testing of vaccine and biological products use these reagents. Reagent lifecycle includes; acquisition, certification and qualification testing, implementation and ongoing monitoring and replacement of the material as needed. Additionally, the individual will work independently and demonstrate leadership in the implementation, execution and management of reagents, as well as perform appropriate second person peer document reviews, support activities and project work associated with their position, and ensure work is conducted to the highest quality, compliant and conforms to current Good Manufacturing Practices and regulatory expectations. Provide bioanalytical support to Global MMD sites as needed and respond to regulatory questions, author of analytical license sections and support regulatory inspections.

Skills:

Required Experience and Skills: 
Bachelor's with 2-5 years' of laboratory experience. 
Demonstrated leadership and teamwork skills and ability to work independently. 
Strong technical knowledge and high level of technical performance. 
Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation. 

Preferred Experience and Skills: 
Previous technical and/or analytical problem solving experience in vaccine or biologics development, and/or quality site experience. 
Proficiency in classical biochemistry or virology assays. 
Experience in the following assays: ELISA, PCR, RNA Extractions, TCID50 assays, virus titering, serum neutralization assays, plaque assays, cell culturing, Ouchterlony, cell banking 
GMP experience. 
Statistical analysis experience with familiarity with JMP.

Education: B.S. in Biochemistry, Virology or related biological science 



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
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Princeton , NJ 08540 
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