Sr QA Material Supplier Specialist (Qualification)
Regeneron
5 hours ago
On-site
East Greenbush, NY
Operations
QA Material Supplier Specialist – Qualification implements activities within the material qualification program to support the utilization of raw materials in Drug Substance and Drug Product Manufacturing.
Responsibilities:
- Perform activities associated with qualification of raw materials (e.g., development of sampling and testing protocols, review of test data, drafting summary reports); execution of sampling activities may be on the floor
- Represent Quality Assurance in support of deviations, change controls, CAPAs, including active participation in investigations, evaluation, and problem resolution
- Provide guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards
- Support and/or approve Supplier Corrective Action Requests (SCARs)
- Work with suppliers to obtain documentation to support closure of Supplier Corrective Action Request Follow-Ups (SCARFs)
- Review/approve Drug Product Component supplier-specific documentation (e.g., Approved Supplier Approvals and TSE/BSE assessments)
- Support relevant departments in the utilization of Drug Product Test Components
- Establish, review, and edit controlled documents
- Continually evaluate processes and procedures for continuous improvement; identify gaps and develop feasible correction plans
Qualifications (required):
- Bachelor’s degree
- QA Material Supplier Specialist: 3+ years relevant experience
- Senior QA Material Supplier Specialist: 5+ years relevant experience
- May substitute proven experience for education requirement (level determined by qualifications relevant to the role)
Skills/requirements (preferred/role fit):
- Quality-driven, organized, and detail-oriented
- Good written, verbal, and interpersonal communication skills; ability to interact cross-functionally
- Ability to navigate changing priorities; prioritize, manage multiple tasks, and meet deadlines
- Ability to learn and use computerized systems for daily tasks
- Ability to lift up to 25 lbs
- Comfortable working in a warehouse environment 20% of the time
Application instructions:
- Apply now to take your first step towards living the Regeneron Way!
Benefits (if explicitly stated):
- Health and wellness programs (including medical, dental, vision, life, and disability insurance); fitness centers; 401(k) company match; family support benefits; equity awards; annual bonuses; paid time off; and paid leaves (e.g., military and parental leave)
Salary Range (annually):
- $67,400.00 - $128,700.00
Responsibilities:
- Perform activities associated with qualification of raw materials (e.g., development of sampling and testing protocols, review of test data, drafting summary reports); execution of sampling activities may be on the floor
- Represent Quality Assurance in support of deviations, change controls, CAPAs, including active participation in investigations, evaluation, and problem resolution
- Provide guidance internally and externally to ensure quality and regulatory expectations are met in relation to material quality standards
- Support and/or approve Supplier Corrective Action Requests (SCARs)
- Work with suppliers to obtain documentation to support closure of Supplier Corrective Action Request Follow-Ups (SCARFs)
- Review/approve Drug Product Component supplier-specific documentation (e.g., Approved Supplier Approvals and TSE/BSE assessments)
- Support relevant departments in the utilization of Drug Product Test Components
- Establish, review, and edit controlled documents
- Continually evaluate processes and procedures for continuous improvement; identify gaps and develop feasible correction plans
Qualifications (required):
- Bachelor’s degree
- QA Material Supplier Specialist: 3+ years relevant experience
- Senior QA Material Supplier Specialist: 5+ years relevant experience
- May substitute proven experience for education requirement (level determined by qualifications relevant to the role)
Skills/requirements (preferred/role fit):
- Quality-driven, organized, and detail-oriented
- Good written, verbal, and interpersonal communication skills; ability to interact cross-functionally
- Ability to navigate changing priorities; prioritize, manage multiple tasks, and meet deadlines
- Ability to learn and use computerized systems for daily tasks
- Ability to lift up to 25 lbs
- Comfortable working in a warehouse environment 20% of the time
Application instructions:
- Apply now to take your first step towards living the Regeneron Way!
Benefits (if explicitly stated):
- Health and wellness programs (including medical, dental, vision, life, and disability insurance); fitness centers; 401(k) company match; family support benefits; equity awards; annual bonuses; paid time off; and paid leaves (e.g., military and parental leave)
Salary Range (annually):
- $67,400.00 - $128,700.00