2020-3622 - QA/QC Analyst III, BioMed

Orano USA in Plano, TX

  • Industry: Pharmaceutical/Biotechnology - Research Associate/Quality Control
  • Type: Full Time
  • Compensation: $97,620.00 - 178,640.00 / Year*
position filled
**Job type :** Regular/Permanent


**Job details :**


Orano Med:
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Job Description:

Orano Med is seeking a QA/QC Analyst III, BioMed for our Plano, TX location. Under minimal supervision, this position performs activities in support of clinical API and drug product manufacturing and testing in compliance with QA policies and procedures and FDA GMPs.
Main Duties and Responsibilities:
Production batch record and form distribution in support of manufacturing operations.
Area release for manufacturing
Batch record review to assess completeness, accuracy, and compliance with SOPs
Internal audits of manufacturing and testing operations.
Investigation of events that occur during manufacturing and testing.
Logbook review.
Review and approval of CMC protocol/reports in support of IND submissions.
Review and approval of calibration, qualification and validation reports.
Entry, tracking and timely implementation of corrective actions resulting from audits and investigations.
Inspection, testing, and release of incoming raw materials and packaging components.
Oversight of training program to ensure compliance with training requirements.




Orano Med:
Orano Med has developed new processes for producing high-purity lead-212, a rare radioactive isotope. Lead-212 is currently at the heart of promising research projects in nuclear medicine to develop new treatments against cancer. The innovative approach, known as targeted alpha therapy (TAT), recognizes and destroys cancer cells while limiting the impact on nearby healthy cells.

Job Description:

Orano Med is seeking a QA/QC Analyst III, BioMed for our Plano, TX location. Under minimal supervision, this position performs activities in support of clinical API and drug product manufacturing and testing in compliance with QA policies and procedures and FDA GMPs.
Main Duties and Responsibilities:
Production batch record and form distribution in support of manufacturing operations.
Area release for manufacturing
Batch record review to assess completeness, accuracy, and compliance with SOPs
Internal audits of manufacturing and testing operations.
Investigation of events that occur during manufacturing and testing.
Logbook review.
Review and approval of CMC protocol/reports in support of IND submissions.
Review and approval of calibration, qualification and validation reports.
Entry, tracking and timely implementation of corrective actions resulting from audits and investigations.
Inspection, testing, and release of incoming raw materials and packaging components.
Oversight of training program to ensure compliance with training requirements.


**City :** Plano

Orano is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.
Associated topics: assistant, equipment, internship, lab, laboratory, qa, quality assurance, routine care, sample collection, scientific associate

* Estimated salary


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