Job Title: Compliance Assurance Specialist
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This role requires a detail-oriented individual who can provide quality compliance oversight to the validation department. The primary responsibility is to ensure that processes are in accordance with regulatory requirements and support the implementation of company manufacturing standards policies and procedures.
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* Maintain compliance trackers for quality records and engage with the team on the status of their records, including NOE-Notice of Event, CC - Change Controls, and CAPA - Corrective Action Preventative Action.
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* Support reporting and drive closure of Quality Records, ensuring RFT (Right First Time) submission.
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* C coordinate the reconciliation and return of documents, such as protocols, forms, and logbooks, to the document control department in a timely manner.
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* Support internal and regulatory audits by coordinating requests for the QA Validation team and driving Quality and Compliance in validation activities.
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* Collaborate to identify improvements across sites and develop Validation specific training.
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* Influence the development and revision of local and global policies, procedures, and business processes aligned with industry standards and best practices for Validation.
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This role may be suitable for you if you have:
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* The ability to maintain integrity and honesty at all times.
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* The ability to work independently or as part of a team.
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* Effective communication skills with transparency.
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* A continuous drive to improve processes for improved performance.
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* Demonstrated respectful behavior at all times.
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* Basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
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* Ability to meet commitments on time and follow directions.
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* Effective time management skills.
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To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of experience. Experience within validation or quality compliance is beneficial.
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Benefits: Regeneron offers an inclusive and diverse culture, comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
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EQUAL OPPORTUNITY EMPLOYER: Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, 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.
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Reasonable Accommodation: 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.
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