GCP Quality Consultant
900 Camp Street New Orleans, LA 70130 US
Job Description
- Seasoned Quality professional, willing to "do the work" and be hands-on.
- GMP focus (GLP-GMP rather than GCP)
- Ideally Allergy / Immunology experience but not essential
- Dosage wise, intravenous injectables right now. Going forward will be subcutaneous injectable, prefilled syringe, dual chamber, etc.
- Slower start (10-15 hours per week) but funding dependent, their clinical trial will kick off in 3-6 months out - as such, workload and hours will increase up to 30hrs pw. Possibility for conversion down the road.
- Need to be standalone, able to operate completely independently. Partnering with their existing GMP focused Quality Consultant. Therefore this consultant will have a heavy focus on clinical quality activities: e.g. auditing of investigators, CRO, contract labs, TMF audits, internal systems, etc. This person will play an active role in TMF maintenance, provide input on clinical trial protocols, study reports, develop study audits, assess protocol deviation, study document review, review and approve clinical trial plans. They have a reasonably mature Quality Management Systems (QMS) that will need updating, CAPA generation, etc.
- Culturally they are looking for someone mature - who can make recommendations and do the work.
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