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Sr. Quality Operations Analyst

Quality Operations Analyst (Senior)
Skokie, IL
6 month contract to hire
$30-$35 per hour / $62K-$72K salary
2nd shift (3PM-11:30PM)

Responsibilities:

  • Primary Quality Operations Support of Audits or Inspections
  • Primary Responsibility for the Training and Development of Quality Operations Analysts
  • Primary Responsibility for the scheduling of Oversight Activities and ensuring appropriate adherence to published schedules
  • Processing of Deviations, Complaints, CAPAs and Change Control processes under adherence to the relevant due dates, using the appropriate Quality Management Tool
  • Conduct, coordinate and write Root Cause Investigations
  • Collaborates and supports in defining procedures with regard to cGMP production
  • Responsible for creation, review and approval of Standard Operating Procedures (SOPs)
  • Responsible for review and approval of executed batch records
  • Responsible for Media Fill Observations, Documentation and Reports

Qualifications:

  • Bachelor's degree in an applied science or engineering field or the equivalent work experience
  • 3+ years of experience working in the Pharmaceutical Industry
  • 3+ years of Manufacturing Experience
    • Aseptic Manufacturing is much preferred
  • Knowledge of Quality Systems.
    • Experience implementing QMS
  • Knowledge of Regulatory Bodies & Associated Requirements.

This person will be required to work 8AM-5PM CT for the first 6 months of training.

Sthree US is acting as an Employment Business in relation to this vacancy.