Senior Auditor

US-CA-Seal Beach
Job ID
2017-1036
Category
Other

Overview

Dendreon is looking for senior level auditor with 5+ years experience in Biopharma, Parenterals, Apheresis Sites and Medical Devices. This person is required to have in-depth knowledge of GMP in the US and EU, particularly with respect to aseptic manufacturing of biopharmaceuticals and protein synthesis. The Senior Auditor will be executing internal, external and vendor audits for pharmaceutical, biotech and/or medical device companies to support Dendreon Supplier Quality.

 

May be required to work alternate shifts.

Responsibilities

  • Provide compliance direction to senior managers in various areas within and outside of the Quality organization.
  • Builds and maintains organizational relationships and inspires trust.
  • Be a solutions-based problem solver and work with abstract ideas or situations across functional areas of the business.
  • Interact internally and externally to resolve difficult matters.
  • Provide excellent oral and written communication with clarity of thought.
  • Provide follow-up to visits.
  • Negotiate contracts/agreements.
  • Works well with little direction as an independent contributor.

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent.
  • 10 or more years of related experience in cGMP/FDA regulated industry.
  • 5 or more years auditing experience in Biopharma, Parenterals, Apheresis Sites and Medical Devices.
  • Strong and demonstrated knowledge of FDA regulations and guidance’s for Good Manufacturing Practice in a pharmaceutical environment.
  • Strong background in the principles, science, and regulatory aspects of aseptic manufacturing and protein synthesis.
  • Proficient in MS Office applications.
  • Strong verbal and written communication skills.
  • Well-developed team and collaboration skills.
  • Approximately 50% Air and overnight travel will be required for this position.
  • Ability to gown aseptically for work in Clean Room environments.
  • Ability to gown aseptically for work in a Clean Room environment.
  • Extensive use of laboratory equipment, chemicals and biological materials.
  • May be required to work alternate shifts.
  • Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC) areas. 
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs.

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