Quality Specialist (Supplier)

Job Responsibilities

• Oversee suppliers supporting GMP manufacturing, including qualification, audits, and risk management.
• Maintain relationships with critical and sole-source suppliers, manage quality agreements, and assess the impact of supplier changes.
• Ensure supplier deviations, quality events, and CAPAs are logged, investigated, and resolved per procedures.
• Support risk assessments for suppliers and materials, including data integrity and supply continuity.
• Lead routine supplier meetings and manage Supplier Corrective Action Reports (SCARs).
• Assist with audits/inspections, create/revise SOPs, and support investigations and internal audits as needed.
• Perform other duties as assigned by management.

Qualifications

• Bachelor's degree in a scientific related field preferred
• 5-8 years of quality assurance experience in a GMP-regulated environment
• Strong experience in authoring, reviewing, and maintaining controlled GMP documentation
• Advanced expertise in document lifecycle management, change control, deviation support, and CAPA documentation
• Ability to independently audit new and approved suppliers
• Demonstrated cross-functional collaboration skills with Supply Chain, Manufacturing, and Regulatory teams