layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Senior Quality Assurance Specialist, On the floor (Overnights) at Regeneron Pharmaceuticals

Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team
Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
Maintain project timelines to support the evolving business
Perform on-the-floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents
Review and approval of documents (electronic and paper-based)
Provide mentorship during on-the-floor manufacturing
Support audits, inspections and investigations
Perform quarantine, segregation of material and line clearances
Contribute to the continuous improvement initiatives
Adjust schedule based on facility start up, filling, and manufacturing needs
Collaborate with cross-functional internal teams
The environment and physical rhythms of this role: Gowning: full cleanroom attire (examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs
Let’s find out if we’re a fit: Requires B.S in life sciences or related field and 6+ years of experience; may substitute proven experience for education requirement
Level will be determined based on experience
Thrive today. Grow tomorrow.
Student loan paydown program & tuition reimbursement
Family Care Benefits
Relocation assistance
Inclusion, culture and well-being programs (including physical & mental health)
#REGNQA
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.

Senior Quality Assurance Specialist, On the floor (Overnights)

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