Senior Compliance Specialist-Manufacturing (#370494) 

Limerick, Munster, Ireland

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our outstanding ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous productcandidates in development, all of which were homegrown in our laboratories.Our medicines and pipeline are crafted to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases. Our mission is to use the power of science to bring new medicines to our patients.Summary: Performs all compliance related administrative tasks necessary for supporting commercial manufacturing operations. If you are a strong communicator who is highly organized this is the role for you!Essential Duties and Responsibilities include, but are not limited to, the following:Performs administrative tasks in all areas of production as needed in accordance with cGMP standards.As part of investigations review completed batch records and logbooks.Reviews, edits, and revises controlled documents (batch records, logbooks, SOPs, etc.) to ensure compliance with written procedures.Monitors production processes to acquire necessary data in support of investigations and track efficiency of changes.Participates in cross-functional study teams to support and/or author investigations.Gathers, trends, and analyses process related data to drive consistency and timeliness.Documents all training.Assists with training of new employees.Ensures all tasks are performed in a manner consistent with safety standards.Education and Experience: BS/BA in Life Sciences or a related field and 6-9 years of meaningful work experience.Relevant experience may be substituted in lieu of educational requirement.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.(#IRELIM)Job SummaryJob number: 24195BRDate posted : 2021-04-15Profession: Industrial Operations and Product SupplyEmployment type: Regular Employee

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Regeneron Pharmaceuticals

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