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Associate Quality Compliance Specialist

3 months ago

Ireland Regeneron Pharmaceuticals, Inc Full time

The Associate Quality Compliance Specialist supports data trending, process monitoring, and system administration activities to ensure overall good health of the Quality Management System (QMS). This position will focus on Deviation, CAPA, Change Control and Quality Risk Management elements of the QMS.

A typical day might include, but is not limited to, the following:

  • Managing daily operational activities such as monitoring status of system records, assisting users and record owners, and data trending for reporting metrics and for use in identifying continuous improvement initiatives

  • Assist Senior Quality Systems personnel in support of maintaining, monitoring and improving quality system elements. This may include support in: Maintaining training content / Assisting with the delivery of training, such as scheduling training sessions, maintaining rosters, and collecting feedback / Generating daily task lists for Quality teams / Generating weekly tasks for Quality Teams/Site / Generation of Deviation Evaluation Meeting Minutes. / Scheduling of interdepartmental meetings related to QMS metrics / Monitor Process Performance over time Participate in continuous improvement initiatives

  • Providing administrative support of electronic systems, such as modification of closed electronic records; withdrawals of electronic records; CAPA assignment

  • Assisting as needed in audits and inspections

  • Ensuring global alignment of processes, procedures and methods.

  • May author and /or revise SOPs.

Education and Experience:

Requires a minimum BA/BS degree with 0-2 years of industry/relevant experience or MS with 0-2 years. Relevant experience may be considered in lieu of degree.

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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.

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