We are currently looking to fill a Staff QA Specialist (Technical Development) position. This position supports drug manufacturing internally or at CMO/CDMOs and partners by providing Quality line-of-sight for development, technology transfer and related activities that support validation and commercialization of drug products.
In this role, a typical day might include the following:
Act as a highly experienced, individual contributor equivalent to Manager level
May lead a team responsible for providing support and subject matter expertise to operations at partner sites
Acts as the primary Quality Assurance representative working with External Manufacturing Project Managers, Internal Project Managers and/or Development representatives for all related activities
Helps to establish and maintain partnerships with internal teams and external organizations supporting development, technology transfer, validation, and commercialization of drug products
Ensures consistency in processes through knowledge management activities shared with applicable internal and CMO/CDMO sites
Understands manufacturing equipment functionality; works with project teams during equipment qualification to drive qualification requirements based on product and process knowledge
Resolves problems, identifies trends and developes program improvements related to development and technology transfer across multiple programs and sites
Ensures compliance with internal procedures and regulatory expectations by proactively working internally or with partner Quality organizations
Provides Quality oversight to the process, including review and approval of documents such as process transmittals, process simulations, specifications, initial component qualifications, etc
Participates in Regulatory and internal audits and inspections as subject matter authority.
This role may be for you if you:
Have experience in Quality Assurance, Development, Technology Transfer, Validation, Manufacturing and/or Engineering within the pharmaceutical or biotechnology industry
Excel in a Quality driven organization
Enjoy working with both internal and external partners
Are high collaborative and team oriented
To be considered for this role you must hold a BS or BA in Science or Engineering with the following amount of related experience in a cGMP environment for each 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.