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Commissioning and Qualification Specialist

1 month ago

Thousand Oaks, United States Gabe Inc Full time

Description:

Gabe, Inc. ® is searching for a Commissioning and Qualification Specialist with experience in C&Q activities for equipment and analytical instruments.


Responsibilities:

  • Collaborate with client to develop C&Q strategies in compliance with local, corporate & regulatory regulations.
  • Develop / Approve / Execute IQ, OQ & PQ protocols per approved timeframes.
  • Develop/Approve documentation including, but not limited to: SOPs, Risk Assessments, Validation Plans, RV/IQ/OQ/PQ Protocols, Requirements Traceability Matrices, and Summary Reports
  • Responsible for execution, exception reporting, assisting in exception analysis and resolution in a GMP compliant manner.
  • Manage cross functional team meetings which will interpret the client’s needs and drive decision to meet expectations.


Education:

  • BS/BA in Engineering, Computer Science, Biological or other related discipline or equivalent work experience.

 

Experience:

  • 2-5 years of experience with performing C&Q activities.
  • Technical understanding of production and/or laboratory operations.
  • Previous experience working in an FDA regulated and/or GMP environment.
  • Strong analytical skills with ability to translate sometimes ambiguous data sets into actionable insights and recommendations.
  • Excellent (written and verbal) communication and interpersonal skills, solid organizational skills, and ability to contribute to a collaborative, flexible work environment.
  • Expert knowledge of cGMP documentation practices required
  • Working knowledge in utilizing appropriate root-cause analysis tools & techniques
  • Basic computer skills including experience in the use of Microsoft word, Excel, etc.

 

Benefits:

  • Gabe, Inc.® offers a competitive compensation and benefits package.
  • Position is located at the Amgen Campus in Thousand Oaks, CA.
  • Normal working hours are 8:00 a.m. to 5:00 p.m. Monday through Friday, however irregular working hours should be expected during project execution.
  • Pay is hourly with overtime and is commensurate with qualifications and experience.