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GMP Training Compliance Specialist

Company: Regeneron Pharmaceuticals, Inc.
Location: Troy
Posted on: January 22, 2023

Job Description:

The Technical Training department is hiring! The GMP Training Compliance Specialist position will assist in the identification and implementation of training compliance opportunities to meet IOPS standards and applicable GxP regulations. Additionally, it collaborates with the Technical Training team to ensure business objectives are met. As a GMP Training Compliance Specialist, a typical day might include the following:

  • Supports IOPS Technical Training and organizational training initiatives.
  • Remains current and knowledgeable of key aspects of new or amended regulations and guidelines impacting training by studying existing and new legislation and advising management on needed actions.
  • Focuses on continuous improvement of training materials, programs and processes.
  • Provides support to the internal Technical Training team as well as functional areas completing and documenting training to ensure understanding and compliance of all IOPS and applicable GxP training requirements.
  • Participates on initiatives to implement or change IOPS training systems, procedures and policies as needed.
  • Supports quality system activities such as investigations, internal audits and inspections.
  • Supports internal and external requests for training compliance evidence.
  • Accountable for quality systems activities related to Training change control and documentation updates.
  • Participates on initiatives to implement or change IOPS training systems, procedures and policies as needed.
  • Provides mentorship and ensures continuous improvement to the Quality Training System and the GxP Program according to GxP and current industry standards.
  • Conducts training compliance monitoring and reviews outcomes with functional areas as needed.
  • Defines and reports on training compliance metrics to measure the overall training strategy.
  • Supports functional areas with the evaluation of deviations related to training compliance.
  • Supports fulfillment of the IOPS Annual Training Plan including an Ongoing GxP refresher program.
  • Supports fulfillment of the IOPS Get Connected/Onboarding program; includes delivery of training content.
  • Collaborate with all good manufacturing practices groups and key partners to provide support and oversight of training compliance.This role may be for you if:
    • Current and knowledgeable of key aspects GxP regulations and guidelines.
    • Excellent written, verbal and interpersonal communication skills.
    • Excellent attention to detail.
    • Ability to deliver training.
    • Ability to communicate at all levels and across various functions.
    • Ability to handle internal and external relationships.
    • Ability to prioritize multiple projects and priorities with outstanding organizational and time management skills.
    • Ability to identify, initiate and manage change controls.
    • Ability to write and revise procedures.
    • Ability to perform investigations.
    • Ability to identify and effectively communicate risks.
    • Ability to define problems, collect and analyze data, establish facts, and draw valid conclusions.In order to be considered for this position, you must hold a BS/BA in related field and
      • Assoc Specialist: 0-2 years of experience
      • Specialist: Requires 2+ years of experience
      • Sr Specialist: 5+ years of experience
      • Equivalent combination of education and experience may be considered Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.Salary Range (annually) $55,700.00 - $121,300.00

Keywords: Regeneron Pharmaceuticals, Inc., Troy , GMP Training Compliance Specialist, Other , Troy, New York

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