A Compliance Specialist is primarily responsible for coordination and completion of manufacturing deviations and change controls.
As a Compliance Specialist a typical day might include, but is not limited to, the following:
Coordination and documentation of manufacturing quality events including but not limited to deviations, Change Control’s and CAPA's
Coordinate cross functional teams during Change Control/Deviation events and align team on approach forward
Utilise problem solving methodologies such as fishbone, 5 Whys to establish root cause of deviations
Work closely with Manufacturing Managers to review and evaluate quality event information
Assess event for impact to SISPQ, conduct risk assessments and initiate appropriate corrective actions to prevent recurrence
Technical write up and coordination of internal reviews of investigational reports
Participate in management meetings to update leadership on current status of quality events
Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) in accordance with cGMP standards to ensure compliance with written procedures
Tracks and supervises manufacturings open compliance records
Participates 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.
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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.