We are currently looking to fill a 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).
Available Working Schedule:
Monday-Thursday, 2nd shift
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:
Associate QA Specialist – 2+ years
QA Specialist – 4+ years
Sr QA Specialist – 6+ 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 comprehensive benefits including health and wellness programs, fitness centers and 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. 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)