We are hiring a Principal QA Validation Specialist to support validation and qualification of computer systems within IOPS. The Principal QA Validation Specialist would also plan, coordinate and participate in compliant computer system validation (CSV) process for systems which require formal validation documentation in accordance with regulatory and company manufacturing standards.
In this role, a typical day may include the following:
Generates, executes and/or reviews master and completed computer system(s) qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
Analyzes the results of testing and settles acceptability of results against pre-determined criteria.
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.
Reviews, edits and approves change controls, SOPs, reports and other documentation
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Trains/advises less experienced Specialists.
Leads projects and prepares status reports.
May be required to oversee contingent workers.
This role may be a fit for you if you:
Thrive working in a quality driven environment
Have knowledge in GAMP, 21 CFR PART 11, Annex 11
Continuously aim to improve processes for improved performance
Gather and organize information
Meet commitments on time
Follow directions; performs well-defined tasks
To be considered for this role, you must hold a BS/BA in Engineering, Chemistry, Life Sciences, Computer Science, IT or related field and the following years of experience per each level:
Sr. QA Validation Specialist: 5+ years
Principal QA Validation Specialist: 8+ years
May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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.
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