Quality Assurance Specialists - Manufacturing & Fill Finish - Regeneron Pharmaceuticals

The Quality Assurance Department at Regeneron is Hiring!
The QA Department is comprised of many different areas that perform activities in support of dispositioning product and/or raw materials, while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs (across manufacturing, quality control, materials management, and validation), SOPs, and Regeneron Standard Requirement Documents. Our QA departments focus on inspection readiness and ensure that all information is organized, current and readily accessible in the event of an inspection or audit purposes.
Divisions With Opportunities Include

• CMO/Pack & Label/External Filling
• Material Supplier Quality/Raw Materials
• Investigations
• Change Control
• Regulatory & Compliance
• On-the-Floor QA
• Batch Record Review
• GMP/Quality Auditing
• Post-Marketing Operations/Complaints
• Visual Inspection
• Validation (Fill Finish, Oversight, Cleaning, Equipment, CTU/Refrigeration, CMO, CSV)
• Filling/Fill Finish

As a member of the QA team, a typical day might include the following:

• Ensure all aspects of Quality Compliance for the Rensselaer site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management
• GMP Start Up activities, including tech transfer, equipment start-up and technical training development programs
• Train and/or mentor junior employees, including providing insights and education on processes and procedures
• Generates, implements and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
• Performs all compliance related tasks necessary to review and approve investigations and provide quality oversight to the implementation of robust corrective actions for supporting manufacturing operations
• Perform On-The-Floor quality review of documents, such as: equipment logs, training records, testing results, batch records and supporting documents (electronic and paper based)
• Work on and potentially lead efforts to establish new programs to support Drug Product facility including start-up of formulation, filling, inspection, assembly, and pack and label team
• Represent Quality Assurance in support of sophisticated Deviations (NOEs & DNFs), Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution; prepare written reports to management on findings
• Identify gaps in systems and develop feasible plans for correction; participates in regulatory and customer audits
• Qualification of raw materials, components, equipment, utilities, automation, shipping and validation of cleaning and sterilization processes
• Represents the organization on behalf of QA with external partners to communicate QA policy and procedures; collaborate closely with external partners and provide input on regulatory communications
• Review, edit, or approve Regeneron controlled documents

In Order To Be Considered, You Must Hold a Bachelors Degree In Scientific Subject Area Or Related Field And The Following Amount Of Relevant Experience For Each Level

• Senior Specialist: 6+ years
• Specialist: 4+ years
• Relevant experience may be substituted for education requirement. Level is determined based on qualifications relevant to the role.
• Associate: 0-2+ years
• Associate Specialist: 2+ years

#REGNQA
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)
$23.29 - $121,300.00