In this role you will be responsible for providing QA oversight and support to manufacturing activities. Performing and leading 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:
Issuing 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
Training and/or mentoring 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 demonstrate:
An understanding of biologics manufacturing operations
Good organizational skills and attention to detail
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
An ability to learn and utilize computerized systems for daily performance of tasks
To be considered for this opportunity you should have aBS/BA in a scientific discipline or related field.
Associate QA Specialist level - minimum 0-2 years relevant experience.
QA Specialist level - minimum 3-5 years relevant experience.
Sr QA Specialist level - minimum 5+years relevant experience.
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.