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Title : ORT- Scientist 2 -216
State : New Jersey   Date : Jun 29, 2022
Experience Level :  
Position Type : Scientist 2      
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: Raritan, NJ

Job Title: Scientist 2

Duration: 8+ months (extendable) contract on W2


Responsibilities:

a. This position is primarily responsible for testing microplates that are coated with Antigens, formulation and in-process testing of reagents, conjugates and controls for Donor Screening Kit Components according to established procedures or approved protocols.
b. Need to be familiar with multiple testing / formulation labs in Donor Screening Area.
c. Donor Screening Kits for ELISA Test Systems includes the following seven components that are product-specific: positive control, negative control, conjugate-antibody, antigen-coated microwell plates, specimen diluent, substrate buffer and o-phenylenediamine 2-HCl tablets.
d. This results in common manufacturing sub-process steps that include formulation of multiple bulks and antigen-coated microplate process.
e. It includes receipt and inspection of incoming raw materials, microplate coating and testing, formulation and in-process testing of reagents, conjugates and controls, filtration and filling of bulks, and release testing followed by kit packaging.
f. Manufactured finished goods are released on acceptable in-process, QA release testing along with concurrent CBER lot release according to set specifications

Duties and Responsibilities:

a. Performs all manufacturing processes in accordance with GMP’s, SOP’s, TMs, safety rules and production schedule.
b. Assist in the manufacture and qualification of In-House panels.
c. Maintains accurate, complete and timely written batch records and documentation.
d. Perform batch record review of documents as needed Knowledge and understanding of test methods and interpretation of test results Accurately complete documentation in batch records, logbooks, systems, forms and other GMP documents.
e. Maintain supplies and test reagent inventory Perform ERP transactions to ensure inventory is accurate.
f. Perform cycle counts and special counts in a timely manner.
g. Assure all raw materials are on-hand as needed for manufacturing processes .
h. Participate in group’s compliance efforts regarding safety regulations and requirements including cGMPs, OSHA, Universal i. Precautions and Product License Agreements.
j. Clean and maintain production areas and equipment according to procedures.
k. Ensure equipment maintenance programs are followed, equipment is calibrated and scheduled preventative maintenance is performed when required.

Qualifications:

a. Bachelor’s degree or better in a science field.
b. 3-5 years of experience in a medical or manufacturing facility.
c. Must have experience working with basic laboratory equipment and procedures.
d. Familiarity with ELISA technology is a plus.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com
NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
4390 US-1, Suite 110 
Princeton, NJ 08540
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