Quality Operations Lead — Packaging & Warehouse

Nephron Pharmaceuticals Corporation; Columbia (SC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Nephron Pharmaceuticals Corporation in Columbia, SC is seeking an Assistant Manager, Quality Operations for Secondary Packaging & Warehouse. You will provide quality oversight and leadership for packaging, warehousing, shipping, returns, and related quality activities to ensure cGMP and FDA compliance.

You will lead investigations, CAPAs, deviations, and audits, coach staff, and drive continuous improvement while maintaining product integrity and adherence to quality systems across finished

Qualifications

• Bachelor's degree in a scientific/technical field preferred.
• Minimum 3 years of pharmaceutical Quality Assurance/Quality Operations experience.
• Secondary packaging, manufacturing, warehouse, distribution experience preferred.
• Minimum 3 years supervisory or lead experience in a GMP environment.
• Experience with deviations, investigations, CAPA, audits, and GMP documentation.
• 2–3 years of experience with Microsoft Word, Excel, and PowerPoint.
• 1–2 years of project management or process improvement experience preferred.

Responsibilities

• Provide Quality oversight for secondary packaging, warehouse, finished goods, shipping, returns, and related Quality Operations activities.
• Ensure compliance with cGMPs, FDA/DEA requirements, SOPs, safety requirements, and Quality Systems.
• Monitor packaging operations, line clearances, labeling, reconciliation, documentation, and housekeeping to prevent errors.
• Review and approve batch records and GMP documentation for accuracy and compliance.
• Lead deviations, NCRs, investigations, CAPAs, root cause analyses, audits and other Quality System activities.
• Identify recurring quality issues and implement corrective and preventive solutions.
• Maintain current knowledge of FDA/DEA/cGMP requirements and communicate changes.
• Coordinate GMP training for Quality Operations personnel and ensure training is current.
• Coach and develop Quality Operations staff to promote accountability and teamwork.
• Support validation, qualification, studies, process improvements, and special projects.

Skills

Pharmaceutical cGMPs

FDA/DEA requirements

Quality Oversight

Deviations/NCRs/CAPAs

Documentation

Team supervision

Microsoft Word/Excel/PowerPoint

Quality Management Systems

Problem solving

Education

Bachelor's degree in a scientific/technical/pharmaceutical/engineering field

High School Diploma or GED

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

Nephron Pharmaceuticals Corporation in Columbia, SC is seeking an Assistant Manager, Quality Operations for Secondary Packaging & Warehouse. You will provide quality oversight and leadership for packaging, warehousing, shipping, returns, and related quality activities to ensure cGMP and FDA compliance.

You will lead investigations, CAPAs, deviations, and audits, coach staff, and drive continuous improvement while maintaining product integrity and adherence to quality systems across finished