Quality Control

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Onsite - Shift flexibility preferred

• Time:
Day or Swing shift pending

IMPORTANT: For the first 7 weeks of the assignment, all contractors are required to work Mon-Fri ) 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 this training.

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 the 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.
• Maintain laboratory instruments for calibration and routine maintenance.
• Author or revise SOPs, qualification/validation protocols, and reports.
• Assist 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.

• Entry level

• Contract

• Manufacturing, Science, and Research

• Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing

This job is currently active and accepting applications.