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GCP Quality Consultant

New Orleans, LA 70130

Posted: 12/04/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 614914 Is job remote?: Yes Country: United States

Job Description

On behalf of our client, a clinical stage biotech focused within Immunology and Allergy, we are looking to hire a strong GCP Quality Consultant (AD-Director level) for 10-15 hours per week with flexibility to increase as work ramps up. Funding dependent this could increase with proof-of-concept study needs or other Clinical Trial work e.g. set up / review of TMFs, CRO qualification etc. This position can be remote but requires East Coast working hours. 
 
  • 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. 


 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About New Orleans, LA

Ready to kickstart your career in the vibrant city of New Orleans, Louisiana? From the enchanting French Quarter to the lively Jazz scene, this city offers endless opportunities for professional growth and personal fulfillment. Dive into the rich culture of Mardi Gras, enjoy world-renowned cuisine like beignets and gumbo, or catch a Saints game at the iconic Mercedes-Benz Superdome. With a backdrop of historic architecture, art galleries like the Contemporary Arts Center, and outdoor escapes in City Park, New Orleans is the perfect place to take your career to new heights. Explore our job listings today and discover why this charming city is the ideal setting for your next professional adventure!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.