Senior QA Specialist

In this role you will work as an integral member of the QA Operational Team and collaborate with QA Operations; Document Control; QA Raw Materials and QA Systems.

A typical day might include, but is not limited to, the following:

• Collaborating with cross functional teams to resolve issues, complete investigations and maintain compliance

• Reviewing and approving documents such as failure investigations associated with deviations and Corrective and Preventative Actions (CAPA's), SOP’s, GxP documents, Change Control documents

• Leading and supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver

• Reviewing procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements

• Providing guidance, mentoring and training to teams

• Supervising and trending metrics associated with site quality systems

• Providing support for Inspection readiness tasks and participating in internal, regulatory and customer audits

This role may be for you if you:

• Demonstrate excellent attention to detail

• Have strong organisational and coordination skills

• Demonstrate excellent interpersonal and communications kills

To be considered for this role, you should have a Bsc/BA in scientific discipline or related field and a minimum of 5 years of relevant work experience in pharmaceutical or related cGMP environment/industry preferably with compliance management experience, or equivalent combination of education and experience.

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.