Quality Control Specialists I/II/III

 No Relocation Assistance Available Position:  Quality Control Specialist I JOB DESCRIPTION

 

The Quality Control Specialist will perform Quality Control quarantine and release activities, testing and reports, raw material specifications, equipment monitoring, and environmental monitoring. Assist in quality-related activities within the Worcester contract manufacturing facility and development of methods and processes

 

JOB RESPONSIBILITIES

 Perform protein chemistry assays (SDS-Page, Western Blot, Isoelectric Focusing, HPLC, Elisa, RID, Spectrophotometric Protein Determination). Perform chemistry assays (TOC analysis of purified water and general testing of materials). Perform microbiological assays (Environmental Monitoring, Sterility, Endotoxin, growth promotion, analysis of contamination, Microbial Identification and Bioburden). Proficient in all Quality Control assays. Ensure that all samples are processed in compliance with Compendia and/or Standard Operating Procedures, in a timely and efficient manner. Write, revise and review SOP?s, forms. Order and maintain QC supplies. Ship test samples to contract test labs. Log test samples into tracking system. Perform test method validations. Perform technology transfer of assays. Process out of specification results (OOS), investigate. Process CAPA reports.Monitor magnahelic gauges.Monitor equipment calibration and calibration checks.Test sample retains.

 

QUALIFICATIONS:

 

The ideal candidate needs a B.S./M.S. related discipline; a minimum of 1 to 3 years of laboratory experience and implementation of Quality Control systems (GMP).  Experience in protein chemistry assays (Elisa, HPLC, SDS-Page, RID, Western Blot, etc.). Experience with microbiology assays and assay development preferred. Excellent verbal and written communication skills and team orientation are required.

 

 

ABOUT BIOVAX AND BIOVEST

Biovax, inc. is the manufacturing and production arm and a wholly owned subsidiary of Biovest International, a publicly traded company (BVTI.OB) and a pioneer in the development of individualized immunotherapies for life-threatening cancers of the blood system. Biovest's therapy for follicular non-Hodgkin's lymphoma, BiovaxID, is currently in a Phase 3 pivotal clinical trial at over 20 major centers in the U.S. being conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute. Biovax manufactures the BiovaxID vaccine in its GMP manufacturing facility in Worcester, MA. Biovest has also been a leader in the manufacture and development of automated cell culture instrumentation for over 20 years. It?s Advanced Instrumentation Division in Minneapolis is poised to introduce the innovative AutovaxID-C cell culture instrument that is expected to revolutionize the manufacture of personalized cell based therapeutics. Biovest and Biovax are seeking highly motivated individuals interested in joining a growing organization developing cutting-edge therapeutics. Biovax provides a competitive salary and a full range of benefits.

For further information, please visit Biovest's website: www.biovest.com or contact:

 

Cathy Maher

Human Resources Administrator

Biovax, a Biovest Company

Biovest International

377 Plantation St. Worcester, MA 01605

508 793 0001 x  509

cmaher@biovest.com