Supplier Quality Assurance Lead (cGXP)

HKA Enterprises; Rocky Mount (NC); Sur place; USD 70 000 - 90 000; Plein temps

Résumé du poste

HKA Enterprises in the United States is seeking a Quality Assurance Specialist (Supplier Quality Management) to oversee supplier performance, QA procedures, and regulatory SME support during inspections.

You will perform supplier QA assessments, interpret cGXP for clinical and commercial environments, resolve complex quality issues, and assist with regulatory audits, aiming at continuous process improvements and compliance.

Qualifications

• Bachelor’s degree in Science with 4+ years of experience (or Master’s with 2+ years, PhD with 0, Associate’s with 8, HS Diploma with 10).
• Industry experience in manufacturing, quality, or engineering within biotech/pharma.
• Strong communication, cGXP knowledge, and supplier management expertise.
• Preferred: QA supplier management, quality agreements, and supply chain.

Responsabilités

• Perform QA assessments, approvals, and qualifications for suppliers and incoming materials.
• Interpret cGXP for commercial and clinical manufacturing environments.
• Resolve complex supplier quality issues independently and implement process improvements.
• Support regulatory audits, provide performance metrics, and coach junior team members.

Connaissances

cGXP knowledge

Supplier management

Communication

Formation

Bachelor’s degree in Science

Master’s degree in related field

Description du poste

HKA Enterprises in the United States is seeking a Quality Assurance Specialist (Supplier Quality Management) to oversee supplier performance, QA procedures, and regulatory SME support during inspections.

You will perform supplier QA assessments, interpret cGXP for clinical and commercial environments, resolve complex quality issues, and assist with regulatory audits, aiming at continuous process improvements and compliance.