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Principal QA Material Supplier Specialist

Company: Regeneron Pharmaceuticals, Inc.
Location: East Greenbush
Posted on: November 26, 2022

Job Description:

The QA Raw Materials department is hiring! The Principal QA Material Supplier Specialist implements and oversees activities performed by Quality Assurance Material & Supplier Quality within the material qualification program to support the utilization of materials in Drug Substance and Drug Product Manufacturing.As a Principal QA Material Supplier Specialist, a typical day might include the following:

  • Performing activities associated with qualification of raw materials (single-use disposables, chemicals, drug product components, and medical devices) such as: development and approval of sampling strategies/protocols, testing strategies/protocols, review of test data, summary reports, reconciliation of deviations, etc.
  • Ability to manage direct reports including, but not limited to: development of talent, monthly performance reviews, timecard and training completions, resolution of personnel issues
  • Providing guidance, direction, and assignment of day-to-day tasks within the qualification program
  • Actively communicates program progress and challenges to Management
  • Representing Quality Assurance in support of deviations, change controls, CAPAs, etc. including active participation in investigation, evaluation, and problem resolution
  • Provides guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards
  • Reviews/approves Supplier related documentation
  • Provides direction and support to relevant departments in the utilization of materials from a quality perspective
  • Continually evaluating Regeneron processes and procedures with an eye toward continuous improvement; identify gaps in systems and develop feasible plans for correction.
  • Participates in Regulatory, Partner, and Internal Audits/Inspections and ensure observations are addressed and completed on schedule
  • Compiles quality metrics; proactively takes actions based on dataThis role may be for you if:
    • Excels in a quality driven organization
    • Has the ability to mentor junior employees
    • Capable of organizing priorities and workloads for a team
    • Able to make informed quality decisions
    • Requires good written, verbal, and interpersonal communication skills and the ability to effectively interact cross functionally
    • Able to navigate changing priorities
    • Able to learn and apply computerized systems for daily performance of tasksTo be considered for this role you must hold a BS/BA in scientific subject area or related field and
      • Principal Specialist: minimum 8 years relevant experience
      • Staff Specialist: minimum 10 years relevant experience
      • Relevant experience may be substituted for education requirement 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) $85,800.00 - $157,400.00

Keywords: Regeneron Pharmaceuticals, Inc., Albany , Principal QA Material Supplier Specialist, Other , East Greenbush, New York

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