Senior Quality Specialist – Contract Manufacturing Oversight

NEPHRON SC, LLC; West Columbia (SC); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

NEPHRON SC, LLC seeks a Senior Quality Specialist for Contract Manufacturing to oversee quality for CMOs, coordinate product changes, and ensure compliance with cGMP, FDA regulations, and quality systems. You will liaise across departments, support audits, CAPA, deviations, and timely product release.

The role requires collaboration with development, production, QA/QC, and external partners to maintain regulatory readiness and customer satisfaction.

Qualifications

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, Life Sciences, or related field.
• 3+ years of progressive experience in pharmaceutical manufacturing, quality, or related discipline (sterile injectable/ophthalmic preferred).
• Experience supporting contract manufacturing, customer quality relationships, or product release activities.
• Working knowledge of cGMP and quality regulations.
• Experience supporting regulatory inspections and customer audits.

Responsabilités

• Oversee quality for CMOs and coordinate campaigns and product changes.
• Partner with internal and external stakeholders to meet quality standards.
• Support audits, regulatory inspections, CAPA, deviations, and changes.
• Ensure timely product release with quality compliance.

Connaissances

Quality assurance

cGMP compliance

FDA regulations

Project management

Cross-functional coordination

Documentation accuracy

Communication skills

Regulatory inspections

Formation

Bachelor's degree in Pharmaceutical Sciences / Chemistry / Biology / Engineering

Description du poste

NEPHRON SC, LLC seeks a Senior Quality Specialist for Contract Manufacturing to oversee quality for CMOs, coordinate product changes, and ensure compliance with cGMP, FDA regulations, and quality systems. You will liaise across departments, support audits, CAPA, deviations, and timely product release.

The role requires collaboration with development, production, QA/QC, and external partners to maintain regulatory readiness and customer satisfaction.