Associate Compliance Specialist

2 weeks ago

Dublin, Dublin City, Ireland Regeneron Pharmaceuticals, Inc Full time

Within this role you will be responsible for coordination and completion of manufacturing deviations and change controls.

As an Associate / Compliance Specialist a typical day might include, but is not limited to, the following:

  • Coordinating and documenting of manufacturing quality events including but not limited to deviations and change control's
  • Coordinating cross functional teams during Change Control/Deviation events and align team on approach forward
  • Utilizing problem solving methodologies such as fishbone, 5 Whys to establish root cause of deviations
  • Working closely with Manufacturing Managers to review and evaluate quality event information
  • Assessing event for impact to SISPQ, conduct risk assessments and initiating appropriate corrective actions to prevent recurrence
  • Coordinating of internal reviews of investigational reports
  • Participating in management meetings to update leadership on current status of quality events
  • Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
  • Tracking and supervising manufacturing's open compliance records
  • Participating in regulatory and customer audits

This role might be for you if:

  • You thrive in a multifaceted and fast-paced environment
  • You possess excellent verbal and written communication skills
  • You enjoy problem solving
  • You successfully build and develop strategic partnerships
  • You demonstrate an ability to work within a successful team

To be considered for this opportunity you should have a BS/BA in Life Sciences or a related field and 2+ years of relevant work experience. Relevant experience may be substituted in lieu of educational requirement.

#IRELIM #JOBSIEST #LI-Onsite # REGNIELSM

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. #J-18808-Ljbffr

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