QA Specialist (Analytical Compliance)

We are currently looking to fill a Quality Assurance Specialist (Analytical Compliance) position. This position applies functional knowledge in the Quality function. This position will complete information analysis and assist in implementing industry standard methodologies for GMP across manufacturing, quality control, materials management and validation and will ensure that procedures, products and documentation adhere to internal standards as well as those of the regulatory agencies.

In this role, a typical day might include the following:
• Interacting with Quality Control laboratories, Manufacturing Operations, and Facilities to ensure a successful compliance profile
• Providing consultation or advice in alignment with QA policies
• Actively participating in investigation, evaluation, and problem resolution in support of Deviations, Change Controls, CAPAs, etc. Ensuring that procedures, products, and documentation adhere to internal standards as well as those of the agencies that supervise the pharmaceutical industry around the world.
• Performing activities associated with review, edit, and approval of QC generated documentation. Activities may be on the floor or at a desk.
• Collaborating with key partners in the business to proactively identify areas for improvement and develop solution strategies
• Training and/or mentoring junior employees, including providing insights and education on processes and procedures
• Ensuring safety and operational standards are maintained.

This role may be for you if you:
• Excel in a quality driven organization
• Have an understanding of biologics manufacturing operations
• Have prior experience within a Quality Assurance or Quality Control function
• Experience with facility or laboratory start-up, technology transfer, or validation
• Are organized and have an attention to detail
• Can prioritize multiple assignments and changing priorities
• Are able to learn and utilize computerized systems for daily performance of tasks

To be considered for this role you must hold a Bachelor's degree 0-2+ years of relevant experience for QA Associate level, 2+ years for Associate Specialist level, 4+ years for Specialist level, 6+ years for Senior level. 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 steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for 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 maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
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