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 step towards living the Regeneron Way!
We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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.
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.
For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency.
If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process.
Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted.
The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
