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Stability Quality Assurance Manager

The Fountain Group San Jose ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

My name is Casey Ashley, and I am a Recruiter with The Fountain Group.  We are a national staffing firm and are currently seeking a ­­­­­­­­    Stability Quality Assurance Manager          for a prominent client of ours.  This position is located in Frederick, MD Details for the position are as follows:

Job Description:

 

  • Responsible for ensuring compliance with company’s commercial stability obligations through designing, implementation and maintenance of the Stability Program for biologics products.
  • Generation and maintenance of the Stability Program for assigned products (drive stability study designs, author protocols, GQCLIMS Stability Static Data-load in collaboration with key stakeholders
  • Plans, designs, and executes multiple simultaneous projects that are complex and technically demanding through significant interactions with internal and external cross functional stakeholders.
  • Acts as a subject matter expert for stability program of assigned products. Drives the implementation of post marketing changes (new container closure systems etc) into stability program.
  • Supports technology transfers by coordinating with sending units to ensure seamless transfer of stability programs.
  • Ensures that assigned biologics stability program fulfils all regulatory requirements, and is optimized and effective.
  • Supports all stability data communication to customers
  • Supports regulatory submissions (author/co-author relevant regulatory filing sections).
  • Technical support related to Stability (Product Complaint, Deviations, Change Controls).
  • Supports regulatory agency inspections for stability-related questions.
  • Identification of any issues that may result in stability related non-compliance with GMP, regulatory requirements or commitments.
  • Seek opportunities for continuous improvement, across all aspects of global stability management
  • To seek opportunities for continuous improvement across all aspects of Global Stability Management
  • Experience with stability program management of biologics products
  • Experience with license management
  • Experience with continuous improvement processes
  • Experience with LIMS or Laboratory Notebook
  • Experience in analytical or pharmaceutical sciences

 

If you are interested in hearing more about the position please respond to this posting with your resume attached.

Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.

 

Regards,

 

Casey Ashley

casey.ashley@TheFountainGroup.com

Company Description
Looking for a new career, or a change from your current work environment?

The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

The Fountain Group

Looking for a new career, or a change from your current work environment? The Fountain Group gives you access to more opportunities in your area of expertise and allows you to gain advice and skills training that will help you advance in your chosen career field

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San Jose, CA
USA

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