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:
1. Maintaining regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
2. Collaborating with cross-functional teams to resolve issues, complete investigations, and maintain compliance.
3. Reviewing and approving the following types of documents: Failure investigations associated with deviations, Corrective and Preventative Actions (CAPA), Standard Operating Procedures (SOPs), GxP documents & Change control documents.
4. Supporting root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
5. Reviewing procedures, policies, and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
6. Providing guidance, mentoring, and training to teams if/where required.
7. Leading projects and overseeing related activities and the work of project contributors.
8. Monitoring and trending metrics associated with site quality systems.
9. Actively participating in continuous improvement ideas, initiation, and implementation.
10. Providing support for Inspection readiness tasks where required.
11. Reviewing & approving changes in accordance with SOPs.
12. Participating in internal, regulatory, and customer audits.
This role might be for you if:
1. You are a self-starter with the ability to operate in a multifaceted environment, able to work on your own initiative and within a team environment.
2. You have strong organizational and project management abilities, demonstrating good attention to detail.
3. You have previous experience as a Subject Matter Expert (SME) in a highly regulated environment (e.g., pharma, biotech, medical devices).
4. You have a strong background and are 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 a scientific discipline or related field. For Specialist level, a minimum of 3 years of relevant work experience with Quality Assurance is required, and for Sr Specialist, 5+ years of experience with Quality Assurance in a pharmaceutical or related cGMP environment/industry, preferably with compliance management experience, or an 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 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.
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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