Specialist, Training Compliance
Company: Regeneron Pharmaceuticals Inc
Posted on: January 13, 2022
We are currently looking to fill a Specialist, Training
Compliance position. This 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.
In this role, a typical day might include the following:
- Supports IOPS Technical Training and organizational training
- 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
- Focuses on continuous improvement of training materials,
programs and processes.
- Provides support to the internal Technical Training team as
well as functional areas implementing and documenting training to
ensure understanding and compliance of all IOPS and applicable GxP
- 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
- Accountable for quality systems activities related to Training
change control and documentation updates.
- Provides guidance 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.
- Collaborate with all good manufacturing practices groups and
key team members to provide support and oversight of training
This role may be for you if you:
- Are knowledgeable of key aspects GxP regulations and
- Have Excellent written, verbal and interpersonal communication
- Excellent attention to detail.
- Ability to communicate at all levels and across various
- Ability to manage internal and external relationships.
- Ability to handle multiple projects and priorities with
exceptional 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.
To be considered for this role you must hold:
- Requires BS/BA in related field, knowledge of GxP
- Relevant experience in the pharmaceutical/biotechnology
- Associate Specialist 0-2yrs
- Specialist 3-5yrs
- Sr Specialist 5+yrs (MS 4+)
- Level is determined based on qualifications relevant to the
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 amazing benefits including health and wellness
programs, fitness centers and stock for employees at all
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
maternity 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
Keywords: Regeneron Pharmaceuticals Inc, Troy , Specialist, Training Compliance, Other , Troy, New York
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