Sr QA Specialist (Pack and Label)

We are currently looking to fill a Sr Quality Assurance Specialist position to support Assembly, Packaging and Labeling. This position will identify strategic opportunities and solutions, gaining consensus and resolving issues of quality, safety, compliance and efficiency that impacts the Fill/Finish platform for assembly, pack and label operations. You will play an integral role in GMP Start Up activities, including tech transfer, equipment start-up and technical training development programs. The role contributes as a member of cross-functional teams to support the assembly, pack and label platform and functions as an interface between the Quality platform, manufacturing platform, and the Technical Community (especially Engineering/Maintenance and Manufacturing Technology).

In this role, a typical day might include the following:
• Lead QA efforts to establish new programs to support Drug Product facility including start-up of assembly, pack and label operations
• Accountable for maintaining project timelines and delivering results associated with quality assurance initiatives to support the evolving business
• Provides experienced technical advice for fill finish related program decisions
• Provides project support involving technical transfers, engineering projects and similar activities
• Acting as QA representative for development and approval of relevant documents including master batch records, process validations, risk assessments, product/process specifications
• Represent Quality Assurance in support of sophisticated Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Develop and deliver technical training programs
• Review, edit, or approve Regeneron controlled documents
• Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement
• Ensure efficient and effective operation by crafting a proactive environment, developing & monitoring metrics, and communicating with both team members and support functions about operations performance. Works with the QA and Manufacturing Management Committees to drive improvements
• Ensure compliance with all regulatory requirements and good documentation practices are followed to provide a safe, quality, and effective product
• May provide on the floor support and batch record review as needed
• May participate in regulatory inspections
• May participate in industry communities to influence standards
• May manage others

This role may be for you if you:
• Have experience in a drug product manufacturing environment, assembly/pack and label experience preferred
• Possess strong written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally
• Are ability to lead cross-functional teams and manage others through influence rather than direct authority
• Can build relationships and collaborate on cross functional teams
• Have previous experience in Quality Systems

To be considered for this role you must hold a Bachelor's degree in Life Sciences or related field and following minimum amounts of relevant experience for each level:
• Senior QA Specialist - 6+ years
• Principle QA Specialist - 8+ years
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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