Job Description

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

About the Role : A Commissioning and Qualification Specialist will be responsible for collaborating with clients to develop C&Q strategies and executing various protocols in compliance with local, corporate & regulatory regulations.

Responsibilities :

• 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.

Qualifications :

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

Required Skills :

• 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.

Pay range and compensation package :

• 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.

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