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Quality Control Analyst II - Biochemistry/Virology

ArtechInformationSystemLLC

Holly Springs, NC, United States contract

Posted: February 23, 2016

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Quick Summary

Support organization and implementation of new bio- assays for QC testing of raw materials, drug substance, and drug product.

Job Description

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Duties: 

• Support organization and implementation of new bio- assays for QC testing of raw materials, drug substance, and drug product.

• The candidate will assist in all phases of assay development and validation, including experimental design, drafting the new test methods, executing the experiments and analyzing data. 

Essential Functions: 

• The individual is expected to apply critical analysis skills to plan and execute experiments, analyze data, and draw conclusions from results. Additionally, the candidate will:

• Perform laboratory experimentation across a broad spectrum of responsibilities.

• Understand experiments and conduct troubleshooting analysis.

• Ensure that all samples are tested according to quality requirements defined via registered specifications in accordance with local/international regulations.  

• Record data in an accurate and timely manner per applicable regulatory and corporate requirements.

• Prepare culture media, chemicals, reagents and solutions. Maintain sufficient inventory of material, supplies, and equipment for performance of duties; clean and maintain complex laboratory equipment.

• Develop expertise in assigned assays/techniques.

• Write and update standard test methods, as needed.

• Maintain compliance with applicable cGMP requirements.

• Closely adhere to appropriate safety and environmental regulations, particularly with regard to hazardous chemicals and biological materials.

 Secondary Functions: 

• Lead special projects and investigations.

• Perform shift-work as necessary to maintain deliverables schedule.

 Skills:  

• Looking for candidates having less than 2 years’ experience, or have more than 5 years’ experience. 

• The ideal candidates will offer a degree in life sciences or related field with broad bio analytical background and success in a prior role in a relevant lab at a university or a pharmaceutical or biotech firm (minimum 2 years).

• Solid experience with a minimum of four of the following lab techniques: SDS-PAGE, spectrophotometry, ELISA, flow cytometry, tissue culture, RT-PCR, Western Blot, enzymatic assays.

• Experience with Method Development and Method Validation.

• Demonstrated experience working with biological samples.

• Demonstrated strong analytical and creative problem-solving.

• The individual must be able to work with a minimal supervision.

• Proficiency in MS Word, MS Excel, PowerPoint.

• Knowledge of virology or biochemistry is a plus.

• Familiar with a GxP regulations, preferred but not required.

• BS degree in Chemistry, Biochemistry, Biology or other closely related scientific field

For more information, please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960

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