Quality Specialist II (Supplier Quality Acceptance)
Core
Independently perform supplier quality acceptance activities for materials, components, and equipment used in single-use bioprocessing and automation systems, ensuring conformance to specifications and standards.
Role type
Supplier Quality Specialist (Acceptance)
Builds
Single-use bioprocessing and automation systems
Domain
Life Sciences / Bioprocessing / Manufacturing
Required skills
Inspection and measurement techniques, Engineering drawing interpretation, GMP compliance, Nonconformance reporting, Root cause analysis support, Quality documentation management, Risk-based decision making, Supplier collaboration
Preferred skills
None stated
Technologies
ERP/eQMS systems, Inspection equipment
Responsibilities
Perform source inspection, receiving acceptance, and Factory Acceptance Testing (FAT) at supplier sites; Inspect mechanical and electrical components including stainless-steel vessels and fabricated assemblies; Review supplier quality documentation and objective evidence for completeness and accuracy; Document inspection results and discrepancies in required systems; Escalate significant supplier quality issues to leadership; Collaborate with Engineering, Operations, and Procurement to resolve acceptance issues; Support Corrective and Preventive Action (CAPA) activities; Recommend improvements to inspection methods and acceptance criteria.
Seniority
Mid-level, hands-on IC
