Validation Specialist

Company: Gabe, Inc.-- -
Location: Thousand Oaks
Posted on: January 15, 2022

Job Description:

Gabe, Inc. -- - is searching for a Validation Specialist with experience in Commissioning, Qualification and Validation of analytical instruments. Responsibilities: Collaborate with client to develop C&Q strategies that are in compliance with local, corporate & regulatory regulations. Collaborate / Approve / Execute IQ, OQ & PQ protocols per approved timeframes. Develop/Approve documentation including, but not limited to: SOPs, Risk Assessments, Validation Plans, 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 validation activities (preferred analytical equipment). Technical understanding of clinical laboratory operations (desired). 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. -- - Job Requirements: Collaborate with client to develop C&Q strategies that are in compliance with local, corporate & regulatory regulations. Collaborate / Approve / Execute IQ, OQ & PQ protocols per approved timeframes. Develop/Approve documentation including, but not limited to: SOPs, Risk Assessments, Validation Plans, 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.

Keywords: Gabe, Inc.-- -, Thousand Oaks , Validation Specialist, Other , Thousand Oaks, California