Opening For Associate Chemist Quality Control : Fremont

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Amar Annamalai
Amar Annamalai's picture
Opening For Associate Chemist Quality Control : Fremont

 Expertise Scientific Research & Development Education Bachelors Job Type Full-time Location United States - California - Fremont Job Level Experienced
Posting date: December 11, 2014
 
You will be required to use standard operating procedures and good manufacturing practices to conduct testing of products including the extraction of viral, bacterial, and cellular material using QIACubes. Duties may also include biological evaluation of products using PCR and other advanced nucleic acid or serological analysis techniques. You may be asked to participate in projects for troubleshooting, process improvement, and new product transfer.
 
Major Responsibilties:
 
Performs routine testing and analysis of products using different instrument platforms.
Performs initial review on departmental paperwork; completed batch records
Maintains and analyzes lot histories for trends and discrepancies.
Initiates NCARs, CAPAs, Deviations when appropriate.
Performs initial troubleshooting of issues which arise during routine analysis.
Documents test results, problems and other relevant information under cGMPs.
Performs simple revisions and updates to SOPs as necessary.
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.
Keeps department lead or supervisors updated on all issues.
Perform extraction of viral, bacterial, and cellular materials in accordance with approved SOPs.
Conduct qualitative and quantitative nucleic acid assays using the, Roche TaqMan 48, Applied Biosystems 7300 sequence detection system, Novartis Procleix or similar instrumentation.
Minimum Requirements/Qualifications:
 
Minimum BS/BA in Chemistry, Biochemistry, or Bioscience with 0-2 yrs Quality Assurance/Quality Control experience, preferably in the medical diagnostics industry. Demonstrated ability and/or additional experience may be considered in lieu of a BS/BA degree.
Strong laboratory skills including pipetting, safety, and hazardous chemical handling. Understanding of cGMP and how it applies to the work environment is preferred.
High level of reading comprehension and verbal communication skills. Ability to follow written and verbal directions with a high level of accuracy. Must be able to write clear, understandable documentation.
Manual dexterity must be able to lift/move up to 20 pounds.
Intermediate word processing and spreadsheet software skills.
Strong organizational skills to be able to manage priorities and multiple tasks simultaneously.
Ability to perform simple data analysis and to summarize results. Basic math skills including calculation of concentrations and dilutions and a strong grasp of algebraic concepts.
Experience with commercially available diagnostic assays and instrumentation (QIACubes, TaqMan 48, ABI 7300, Procleix, etc) for the quantification of viral nucleic acids (i.e. HIV-1 RNA, HCV RNA, HBV DNA, CMV DNA, HSV-1/2 DNA, EBV DNA, etc) is preferred.
Strong working knowledge of clinical analyzers is preferred.
This position is not eligible for relocation benefits.
Skills/Requirements:
Bachelors
 
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