Sr Quality Operations Engineer

Newton Permanent USD110,000 - USD125,000
  • Join exciting clinical stage biotech company focused on cancer treatment
  • Cutting edge technology recently received Fast Track Designation by the FDA

About Our Client

Our client is privately held and is developing a combination drug product that is focused on highlighting cancerous tissue during cancer surgery.

Job Description

  • Manage supplier qualification and process validation activities at CMOs and suppliers related to clinical and drug product.
  • Manager QA Review and Master Batch Records
  • Lead supplier audits
  • Manage requests for change and nonconformances
  • Monitor performance of suppliers and initiate corrective action as required.
  • Act as the quality representative and assist the team in performing risk assessments.
  • Support equipment qualification process, including calibration and preventive maintenance for in house lab and field equipment to support clinical trials.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • Experience in the biotech or pharmaceutical industry.
  • Experience in CMO operations.
  • Strong verbal and written skills.
  • Capable of working effectively under minimal supervision.
  • Thorough understanding of quality systems, cGMPs/cGCPs
  • Experience leading, training and/or implementing root cause analysis and effective investigation practices.
  • Certified Quality Auditor

What's on Offer

  • Competitive base salary and benefit package
  • Opportunity for career growth and development
  • Opportunity to work on cutting edge technology focused on cancer treatment
  • Remote flexibiliy/Hybrid work enviornment
Moriah Sweeney
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Job summary

Life Sciences
Sub Sector
Healthcare / Pharmaceutical
Contract Type
Consultant name
Moriah Sweeney
Job Reference