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Regeneron
We are currently looking to fill a Quality Assurance Specialist (IT) position. This position is responsible for ensuring IT systems, programs and quality events are robust and meet regulatory agency expectations. You will be a liaison with IT and QA to ensure all aspects of IT related programs are following regulatory agency expectations and Regeneron’s policies and procedures.
In this role, a typical day might include the following:
Serve as a technical Quality Assurance Subject Matter Expert supporting IT related change controls, CAPAs, data integrity initiatives, deviations, internal and external audits and other verticals to ensure a robust, compliant state of programs.
Engage with both Corporate IT and IOPS IT to ensure IT processes and procedures meet Regeneron’s Quality System requirements.
Reviews, edits and approves SOPs.
Responsible for compliance monitoring of area operations, including trending of failures and evaluating effectiveness of corrective actions.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
Participate and support the Quality Risk Management (QRM) principles in the formal and informal risk assessment initiatives.
Provide ongoing support to the Quality Auditing function with respect to IT vendors and audits.
Support the development, review and approval of Quality Assurance Agreements (QAA), along with the Approved Supplier List (ASL) process.
Collaborates, investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Achieves quality objectives by contributing information reflecting best practices in the industry and recommendations to strategic plans and reviews.
Stays current with industry trends and regulatory requirement updates and drives changes and improvements based on trends.
Presents project and program status and metrics to Senior Management.
Leads special projects as assigned.
Some travel may be required (approximately 25%).
This role may be for you if you:
Are able to gather relevant facts, assess and decide to execute; understands impact to areas and seeks input
Are comfortable navigating ambiguity with the ability to help define actions
Have knowledge and experience with Computer Systems Validation and/or IT auditing
To be considered for this role you must hold a Bachelor’s degree in related field and following minimum amounts of relevant experience for each level:
Associate QA Specialist – 2+ years
QA Specialist – 4+ years
Sr QA Specialist – 6+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
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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.
Salary Range (annually)
