QC Scientist

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PRINCIPAL OBJECTIVE OF THE POSITION:

To provide technical, scientific and project support for the Quality Control
- Technical Support team in establishing and monitoring testing procedures, investigations, technical transfer of methods, training of staff, and analysis of data and trends.

• Provides technical support for method transfers, including protocol / report authoring and reviewing, data analysis.
• Leads projects related to Quality Control programs as assigned.
• Trains staff, monitors and oversees testing of Analytical Chemistry methods. In depth understanding of at least one discipline (cell based Bioassay, Immunoassay, Electrophoresis, Separation technology [chromatography].
• Provides technical and operational expertise for training and developing staff, assisting in troubleshooting and performing investigations for out of specification results.
• Writes technical reports, reviews and revises standard operating procedures as needed.
• Assists in troubleshooting laboratory equipment and procedures, taking required corrective action.

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, a related discipline, or its equivalent is preferred
• Minimum of 4 years of experience as a senior analyst in Biologics QC lab or experience in a related biopharmaceutical GLP or GMP laboratory.
• Strong technical experience with analytical methodologies. Perform troubleshooting of instrumentation and methods. Have ability to recognize instrumentation and method issues and provide recommendation on instrument and method improvements for the network.
• Previous experience with method transfer desired.
• Experience with LIMS and Smart lab computer applications a plus.
• Proficient in common computer software applications.
• Strong general laboratory and organizational skills, effective communication skills, both oral and written.
• Strong attention to detail.

Regards

Ankit Gupta | Team Recruitment | Mindlance, Inc. | Office:  |