Quality Control

Onsite - Shift flexibility preferred• Sunday-Wednesday• Time: Day or Swing shift pending IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri (0730-1600) to complete New Hire Orientation and Manufacturing On-boarding Technical Training. After the 7 weeks, the contractor is deployed onto their agreed upon shift. New hires will need to complete Responsibilities (include but are not limited to):• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays.• Work with internal and external resources to maintain lab in an optimal state.• Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Supply information to support generation of CoAs for product release.• Maintains laboratory instruments for calibration and routine maintenance• Author or revise SOPs, qualification/validation protocols and reports.• Asist with lab investigations regarding out of specifications (OOS) results. Participate in determination of root cause for deviations related to analytical procedures.• Provide updates at daily and weekly meetings.• Monitor the GMP systems currently in place to ensure compliance with documented policies.Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.• Gather metric information for use in continuous improvement of areas of responsibility.• Perform other duties as required.