QC Analyst

This position is responsible for a variety product assays in support of Quality Control laboratories.  Performs laboratory testing as per approved SOPs and completes and maintains laboratory records and logs.   

Responsibilities & Duties:

1. Performs cell culture and cell based assays required for lot release and the stability program.
2. Performs ELISA and Flow Cytometry analysis required for lot release and the stability program.
3. Performs DNA isolation, DNA quantification, PCR, genotyping required for lot release and the stability program.
4. Perform testing and documents test results as per approved analytical test methods and GMP guidelines.
5. Responsible for performing lot release testing on a timely basis to ensure lot release goals are met.
6. Performs unexpected and out of specification investigations on a timely basis.
7. Responsible to ensure the equipments are calibrated prior to use.
8. Complies with company safety policies and minimizes risk to self, others and the environment, consistent with the community and industry standards.
9. Actively pursues corporate timelines and milestones set by the QC Manager and upper management.

 Requirements:

1. BS/MS in Biology, Immunology or Biochemistry
2. 1 to 3 years of experience working in a QC laboratory environment.
3. Expertise in one or more of the following areas: ELISA assays, cell culture, cell based assays, PCR, fragment analysis, genotyping
4. Familiar with QC sample handling, tracking.
5. Proficient in Microsoft Word, and Excel, and PowerPoint. 
6. Knowledge of laboratory controls and GMP requirements
7. Demonstrates excellent organizational skills. Attention to detail.
8. Good verbal and written communication skills.
9. Ability to work calmly and effectively in a fast paced, dynamic environment.