Commissioning and Qualification Professional

3 weeks ago


Thousand Oaks, California, United States Gabe, Inc.® Full time

Job Summary:

Gabe, Inc. is seeking a Commissioning and Qualification Specialist to join our team. The ideal candidate will have experience in C&Q activities for equipment and analytical instruments.

Key Responsibilities:

  • Collaborate with clients to develop C&Q strategies in compliance with local, corporate, and regulatory regulations.
  • Develop, approve, and execute IQ, OQ, and PQ protocols within approved timeframes.
  • Develop and approve documentation, including SOPs, risk assessments, validation plans, and summary reports.
  • Ensure execution, exception reporting, and analysis in a GMP-compliant manner.
  • Manage cross-functional team meetings to interpret client needs and drive decision-making.

Requirements:

  • BS/BA in Engineering, Computer Science, Biological Sciences, or a related field, or equivalent work experience.
  • 2-5 years of experience in 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 and excellent communication and interpersonal skills.
  • Expert knowledge of cGMP documentation practices and working knowledge of root-cause analysis tools.
  • Basic computer skills, including Microsoft Office.

What We Offer:

  • A competitive compensation and benefits package.
  • A position 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, with occasional irregular working hours.
  • Hourly pay with overtime and commensurate with qualifications and experience.


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