We are currently looking to fill a Staff QA Specialist (Filling) position with our Drug Product Quality Assurance team. This position will support Quality Assurance initiatives for a broad range of topics relative to the start-up and operations of a Drug Product facility. This position is an outstanding opportunity to be a member of the QA Internal Drug Product Fill/Finish management team, crafting the QA policies, programs, procedures and projects for a new innovative start-up fill/finish site. This individual contributor role will identify strategic opportunities and solutions, gaining consensus and resolving issues of quality, safety, compliance and efficiency that impact the Fill/Finish platform. Be a part of 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 Fill/Finish platform and functions as an interface between the Quality platform, Fill/Finish platform, and the Technical Community (especially Engineering/Maintenance and Manufacturing Technology). This role will also serve as a mentor for junior level team members and develop the Fill/Finish team.
In this role, a typical day might include the following:
Individual contributor with the ability to make management level decisions
Provides experienced technical mentorship for fill finish related program decisions
Provides Project support and interface for technical transfers, engineering projects and similar activities
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 and CAPAs, including active participation in investigation, evaluation, and problem resolution
Develop and deliver technical training programs
Continually evaluate Regeneron processes and procedures with an eye toward continuous improvement
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 as needed
May participate in regulatory inspections
Operation Specific Tasks - Filling:
Develop and approve filling operation policies, process and procedures
Train technical aspects of filling operations to the on-the-floor quality group including observance of interventions and response to atypical events (e.g. glass breakage, holes in isolator gloves)
Serve as technical expert for filling tech transfer, start-up operations, sophisticated quality investigations and questions
Experience with filling with isolator and RABs
Experience with sterilization through VHP and/ or autoclaves
This role may be for you if you:
Have experience with facilities start-up operations
Understand biologics manufacturing operations
Are able to lead cross-functional teams and influence policy
Can manage others through influence rather than direct authority
Have courage to change and embrace change
Have worked with Operations personnel for at least 2-4 years in a project position with growing levels of responsibility
Have at least 6 years experience in GMP environment, specifically one or more of the following: pharmaceutical filling, packaging/labeling, assembly, and/or visual inspection.
To be considered for this role you must hold a BS or BA in Life Sciences or Engineering with the following amount of experience in Pharmaceutical Filling, packaging/labeling and/or visual inspection for each level:
Principal QA Specialist – 8+ years
Staff QA Specialist – 10+ years
Sr Staff QA Specialist – 12+ 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.