Regeneron Pharmaceuticals, Inc.
Troy, NY, United States
Biotech, Pharmaceutical, Compliance
Dec 07, 2021
Mar 22, 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 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 implementing 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.
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 compliance.
This role may be for you if you:
Are knowledgeable of key aspects GxP regulations and guidelines.
Have Excellent written, verbal and interpersonal communication skills.
Excellent attention to detail.
Ability to communicate at all levels and across various functions.
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 requirements.
Relevant experience in the pharmaceutical/biotechnology Industry.
Associate Specialist 0-2yrs
Sr Specialist 5 yrs (MS 4 )
Level is determined based on qualifications relevant to the role.
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 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 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 need.
Regeneron Pharmaceuticals, Inc.
Website : http://www.regeneron.com/