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QC Analyst III

Dynavax Technologies

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Location: Berkeley, CA Posted Date: 4/29/2013 Position Type: Full time Job Code: 1107 Required Education: Bachelors Degree

Description

Dynavax has a position open for a Quality Control Analyst III in the Analytical Development/Quality Control group supporting early to late stage drug development. Perform quality control sample testing in support of drug development projects. Participate in test method optimization, qualification, and validation as required;Record and review original test data and follow established company standard operating procedures and good documentation practices.Perform raw data and analytical testing review from contract testing labs.Participate in laboratory maintenance activities, including coordinating and monitoring supply inventories and equipment maintenance and calibration status.Create, revise and update laboratory protocol and procedures.Maintain QC systems cGMP and cGLP complianceStay current on applicable regulation and guidance from FDA, EMEA, ICH, USP, etc. Participate in deviation, OOS/OOT investigation and reporting.May be asked to act as Subject Matter Expert (SME) for specified test method(s) and provide training and present results as needed.Work as a member of a fully integrated team.Other duties as assigned.Position requirements are a B.S. in Biochemistry or a related field with at least five to eight years or MS with two to five years of experience in Quality Control testing in a GMP/GLP environment. Enjoy working in the laboratory. Hands-on experience in wide range of analytical techniques to assess the quality of biopharmaceutical products in a Quality Control environment is a must (LAL, SDS-PAGE, UV, ELISA, HPLC, CE and others). Must be proficient with MS Word and Excel; proficiency with SoftMax Pro and statistical software desired. The ideal candidate is an independent worker, a self-starter with strong organizational and planning skills and has an ability to be productive and successful in an intense work environment. Demonstrated good judgment, excellent attention to detail, excellent written and verbal communication and interpersonal skills are required with the ability to be flexible and collaborate on multiple projects.

Requirements

Position requirements are a B.S. in Biochemistry or a related field with at least five to eight years or MS with two to five years of experience in Quality Control testing in a GMP/GLP environment. Enjoy working in the laboratory. Hands-on experience in wide range of analytical techniques to assess the quality of biopharmaceutical products in a Quality Control environment is a must (LAL, SDS-PAGE, UV, ELISA, HPLC, CE and others). Must be proficient with MS Word and Excel; proficiency with SoftMax Pro and statistical software desired. The ideal candidate is an independent worker, a self-starter with strong organizational and planning skills and has an ability to be productive and successful in an intense work environment. Demonstrated good judgment, excellent attention to detail, excellent written and verbal communication and interpersonal skills are required with the ability to be flexible and collaborate on multiple projects.
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