US-Frederick: QC Analyst - QC Product Testing

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Date: 29-Jan-2008

QC Analyst - QC Product Testing

Perform immunoassay, plasma, DNA, analysis, and other Quality Control procedures. Prepare SOP's and train the appropriate personnel.

Essential Job Functions: Perform immunoassay, plasma, DNA analysis, and other Quality Control procedures. Prepare SOP’s and train the appropriate personnel. Assist in technology transfer. Prepare and execute installation, operation, and performance qualifications. Evaluate, implement, and validate new procedures. Prepare validation protocols, perform validation experiments, and prepare validation reports. Conform to all GLP/GMP requirements.

Additional Job Functions: Perform immunoassay, plasma, and DNA for in-process and final product testing to support the release of licensed products and Phase III products.

Maintain instrumentation and other laboratory instrumentation according to maintenance schedules and GMP requirements.

Train other analysts in Quality Control procedures.

Calibrates and maintains equipment according to standard operating procedures.

Identifies and troubleshoots equipment problems.

Reviews data obtained for compliance to specifications and reports abnormalities.

Prepares validation protocols, executes experiments, and prepares validation reports.

Responsible for writing new SOP’s or revising existing documentation.

Prepares documentation for presentation to Regulatory Agencies.

Applies critical thought to solving problems of complex scope.

Works on technically complex problems where analysis of situations or data requires an in-depth evaluation of intangible factors.

Acts independently to determine methods and procedures on new assignments.

May provide guidance for lower level personnel.

Applies knowledge of good manufacturing practices and good laboratory practices on a daily basis. Adheres to Company safety procedures and guidelines on a daily basis.

Job Requirements

Typical Education: Bachelors: Sciences

Typical Experience: 5-7 years experience

Technical Knowledge: cGMP, Elisa, Electrophrosis, UV Spectrophotometer, Karl Fisher Titrator, Radioactivity

Computer Skills: LIMS, EDMS,CLSD,TestTrack, Excel, Softmax, Word

To apply for this position, please visit this Website.

Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/