This role supports and maintains compliance of QA Operational Team, inclusive of but not limited to QA Operations; Document Control; QA Raw Materials and QA Systems with mandated regulatory requirements and site expectations.
As a QA Specialist/ Sr QA Specialist a typical day might include, but is not limited to, the following: Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
Collaborating with Cross functional teams to resolve issues, complete investigations and maintain compliance.
Reviewing and approving of the following types of documents: Failure investigations associated with deviations, Corrective and preventative actions (CAPA), Standard operating procedures (SOP's), GxP documents & Change control documents.
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 if/where required.
Leading projects and overseeing related activities and the work of project contributors.
Monitoring and trending metrics associated with site quality systems.
Actively participate in continuous improvement ideas, initiation, and implementation.
Providing support for Inspection readiness tasks where required.
Reviewing & approving changes in accordance with SOPs.
participating in internal, regulatory and customer audits.
This role might be for you if: You are a self-starter with the ability to operate in a multifaceted environment, able to work on own initiative and within a team environment You have strong organisational and project management abilities, demonstrate good attention to detail You have previous experience as SME in highly regulated environment (e.g.
pharma, biotech, medical devices) You have a strong background and familiar with site change control, risk management and data integrity initiatives/programs To be considered for this position you must hold a BSc/BA in scientific discipline or related field.
For Specialist level a minimum of 3 years of relevant work experience with Quality Assurance and Sr Specialist requires 5+ years experience with Quality Assurance in pharmaceutical or related cGMP environment/industry preferably with compliance management experience, or equivalent combination of education and experience.
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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. 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.
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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.