Sr QA Specialist (Drug Product)
We are currently looking to fill a Senior or Principal Quality Assurance Specialist (Drug Product) position. 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.
Available Work Schedules:
• Tuesday-Friday, 2:30pm-12:30am (2nd shift)
• Wednesday-Saturday, 6:00am-4:30pm (1st shift)
In this role, a typical day might include the following:
• Work on and potentially lead efforts to establish new programs including start-up of formulation, filling, inspection, assembly, and pack and label team.
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug product operations; where current documents are not adequate, identify path forward for establishment of procedures
• Develop, write, review, and approve SOPs, specifications, and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
• Accountable for maintaining project timelines to support the evolving business
• Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents.
• Review and approval of documents (electronic and paper-based)
• Execute daily operations per management in a multifaceted environment.
• Perform daily on-the-floor duties to ensure facilities, equipment, materials and documentation comply with SOPs and safety standards.
• Provide mentorship during on-the-floor manufacturing
• Support audits, inspections and investigations
• Perform quarantine, segregation of material and line clearances
• Contribute to the continuous improvement initiatives
This role may be for you if you:
• Are able to adjust schedule based on facility start up, filling, and manufacturing needs.
• Possess the ability to multi-task/own multiple projects while ensuring each is progressing as planned against defined timelines
• Are good at establishing relationships and working/collaborating on cross functional teams
• Can develop performance measures and reports to be presented to management which demonstrate progress and status of projects
• Are able to gown for an “A” classification work environment
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.