Quality Ops Lead, Packaging & Warehouse

NEPHRON SC, LLC; West Columbia (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

NEPHRON SC, LLC is seeking an Assistant Manager, Quality Operations, Secondary Packaging & Warehouse to lead quality oversight of packaging, warehousing, and related operations.

The role ensures cGMP and FDA/DEA compliance, reviews batch records, leads deviations and CAPAs, and coaches staff to sustain a strong quality culture.

You will drive continuous improvement, maintain QA documentation, and coordinate training to keep QA systems current and effective.

Qualifications

• Bachelor's degree in a scientific/technical field preferred; HS diploma acceptable.
• Minimum 3 years of pharmaceutical QA/Quality Operations experience.
• Experience in secondary packaging, warehousing, and finished goods.
• Minimum 3 years supervisory or lead experience in a GMP environment.
• Experience with deviations, investigations, CAPA, audits, and GMP documentation.
• Strong attention to detail, communication, and teamwork.

Responsibilities

• Provide quality oversight for secondary packaging, warehouse, and shipping.
• Ensure compliance with cGMP, FDA/DEA, SOPs, safety requirements, and applicable Quality Systems.
• Review batch records and GMP documentation for accuracy.
• Lead deviations, NCRs, investigations, CAPAs, and audits.
• Coordinate GMP training and ensure staff training current.
• Support process improvements and validate/qualify QA activities.
• Escalate deviations and maintain product traceability.
• Oversee finished goods picking, packing, and shipping integrity.

Skills

pharma cGMPs

FDA/DEA requirements

secondary packaging

line clearance

batch documentation

CAPAs

root cause analysis

documentation

MS Word/Excel/PowerPoint

Quality Management Systems

Education

Bachelor's degree in science/engineering

High School Diploma or GED

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Quality Management System software

Job description

NEPHRON SC, LLC is seeking an Assistant Manager, Quality Operations, Secondary Packaging & Warehouse to lead quality oversight of packaging, warehousing, and related operations.

The role ensures cGMP and FDA/DEA compliance, reviews batch records, leads deviations and CAPAs, and coaches staff to sustain a strong quality culture.

You will drive continuous improvement, maintain QA documentation, and coordinate training to keep QA systems current and effective.