Quality Control Analyst 2

Job Description

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.

Qualifications

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

Additional Information

For more information, please contact

Akriti Gupta

(973) 967-3409

Morristown, NJ 07960