In this role you will be responsible for providing QA oversight and support to manufacturing activities.  Performs and leads activities in support of dispositioning product while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. The successful candidate will be required to work shift which includes a mix of days & nights

As a QA Specialist a typical shift might include, but is not limited to, the following:

Providing QA oversight & support to manufacturing activities within the manufacturing areas to support: Issue resolution in conjunction with key stakeholders, including:  Quality point-of-contact for troubleshooting and documentation of equipment/process/schedule disruptions, Triage of potential non-conformances including securing necessary documentation for investigation team in real-time, Support of/counter signing annotations, Perform area walkthroughs, Provide oversight and review of documentation for non-routine work such as Area in PAAS, Incursions, Changeover, Support Inspection readiness, Support SOP/Manufacturing Record review for usability and fitness for use, Participate in shift huddles to provide QA observations and QA perspective on containment for ongoing operations and activities

Performing and leading consultation or advice in alignment with QA policies

Representing Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution

Representing the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications

Providing training and/or mentorship to employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization

Performing activities associated with disposition of product (e.g., manufacturing record review, document review, etc.)

Reviewing, editing, or approving Regeneron controlled documents

Reviewing and approving investigations associated with product or processes

Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement

This role might be for you if you have:

An understanding of biologics manufacturing operations

Strong GMP knowledge

You have previous experience as SME in highly regulated environment (e.g. pharma, biotech) in both internal and external regulatory audits

Good organizational skills and attention to detail

You have solid understanding of Data Integrity

Good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally

The ability to prioritise multiple assignments and changing priorities and meet deadlines

To be considered for this opportunity you should have a BS/BA in a scientific discipline or related field QA Specialist level - minimum 3-5 years experience within Quality.  Sr QA Specialist level - minimum 5+years experience within Quality. Relevant experience may be substituted for education requirement.

#LI-Onsite #IREADV #JOBSIEPR #REGNIEQA 

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.