Bio-Pharmaceutical QA SME

Foster City, CA

Industry: Pharmaceutical Job Number: 134704

 

Aseptic Investigator (CMO)

Project Description:

Our client is a large Bio-pharmaceutical company that focuses on creating drugs for life-threatening diseases. Our client is in need of a Quality Investigator to support the aseptic investigations from their CMOs.

  Day-to-Day Responsibilities:

Our client is in need of support for their Quality CMO department. Currently they oversee 5 clients; all which as aseptic filling. On a day to day basis, this person would be responsible for reviewing and performing analysis on aseptic investigations. This person must have a strong background in aseptic investigations including aseptic filling, environmental monitoring and HVAC investigations. This consultant will also be supporting any CAPAs and interfacing with CMOs. This person must be comfortable being hands-on, writing up reports, performing analysis, reviewing documents and assessing  any impacts to patient safety. 

 

Required:

  • Bio-Pharmaceutical 

  • Aseptic Investigations

  • Aseptic Filling, EM, HVAC investigations

  • CMO experience 

  • Objectionable organisms 

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