Clinical Operations

  • location: Sunnyvale, CA
  • type: Contract
  • salary: $42.50 - $50 per hour

job description

Clinical Operations

Training Specialist

True Title: Quality Systems GXP Training Specialist

Job Summary

Reporting into the Quality Training department, this position will work in a team setting and will be responsible for ensuring GXP training compliance is performed by the organization in accordance with company policies and procedures. Also be responsible for the development, implementation and delivery of a comprehensive training curricula and program for GXP applications.

Job Responsibilities

  • Work with Document Control group in conjunction with generation of SOPs to develop and implement training assignments to affected staff members
  • Develop, design and monitor computer based training courses to ensure that content and effectiveness verification requirements are in compliance
  • Evaluate training courses and monitor subject matter instructors to ensure that training content is appropriate and relevant.
  • Develop an effectiveness verification process for GXP required training
  • Provide reminders on GXP training completion status and escalate as required.
  • Acquire and maintain in depth knowledge of GXP compliance trends in order to deliver / design high quality and highly relevant training to the PCYC organization.
  • Create, develop, and revise Standard Operating Procedures as appropriate to ensure compliance with GXP requirements.
  • Develop training metrics to optimize the performance of the training system to ensure productivity and effective resource planning.
  • Serve as the subject matter expert for training in support of partner and regulatory agency inspections.
  • Assist with implementation of various projects, e.g., an e-LMS, develop curricula, etc
Education & Qualifications

  • BS/BA degree and a minimum of 6 years of related experience
  • Must have extensive experience delivering training presentation in a GXP environment.
  • Must have extensive experience navigating an electronic training and learning system. Experience with developing and implementing e-LMS is highly preferred.
  • Must have an understanding and application of GXPs in the development, clinical testing, and commercial manufacture of pharmaceuticals products.
  • Knowledge and understanding of the current pharmaceutical industry and applicable domestic and international regulations.
  • The ability to work with subject matter experts to develop and present diverse training topics
  • A general knowledge and understanding of adult learning concepts

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

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