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Commissioning and Qualification Specialist
1 month ago
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.