US-CA: QC Chemist

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Date: 18-Aug-2009

QC Chemist II

Position Summary:

Using standard operating procedures and good manufacturing practices, responsible for conducting routine and non-routine analysis of incoming raw materials, work-in-process materials and/or matched kits and filled bottle reagents. Receives general instructions on routine work and detailed instruction on new assignments.

Major Responsibilities:

Conducts routine analysis of microparticle and diagnostic products including raw materials, intermediates and/or matched kits and filled bottle reagents according to approved SOPs. Performs troubleshooting on routine analysis. Documents test results, problems and other relevant information. Reviews documentation. Revises and updates SOPs as necessary. Assists Product Transfer in developing specifications and procedures for QC. Participates in interdepartmental meetings. Performs other responsibilities to support the needs of the department as assigned by Supervisor. Acts independently to determine methods and procedures on new assignments.

Requirements:

Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 2-5 yrs relevant experience, preferably in the Quality Assurance/Quality Control field. Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree. Strong working knowledge of microparticle technology required (prior experience in biotin binding, mRNA, polymer polymerization, microbial testing, and % solid testing using various analytical instruments preferred). Manual dexterity. High level of verbal communication skills. Strong troubleshooting skills. Understanding of cGMP and how it applies to the work environment. High level of reading comprehension skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear, understandable documentation. Intermediate word processing and spreadsheet software skills. Strong organizational skills to be able to manage multiple tasks simultaneously. Skilled at analyzing data and summarizing results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts. Basic statistics skills including regression and correlation.

Education: Bachelors

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BioTech FYI Center
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