QC Chemistry Operations Lead — Drive Lab Excellence & Compliance

RXinsider LTD.; Columbia, Northern (SC, KY); Hybrid; USD 85,000 - 105,000; Full time

Job summary

Nephron Pharmaceuticals in West Columbia, SC, is seeking a senior leader to oversee the QC Chemistry Laboratory. The role ensures FDA and DEA compliance, drives process improvements to reduce lead times, and maintains quality across testing, data integrity, and documentation.

You will recruit, train, and mentor staff while coordinating with Quality and Production to meet regulatory expectations and product release standards.

Qualifications

• Bachelor’s degree in Chemistry or related field with 5+ years in QC Chemistry or R&D.
• Experience with cGMP documentation systems and quality control
• Preferred experience in analytical method development, transfer and validation

Responsibilities

• Plan, organize, and manage resources for sample testing and workflow.
• Verify notebooks, raw data, and COAs before final QC approval.
• Assist in establishing KPIs and reporting for the department.
• Draft, edit, and approve SOPs related to analytical services and equipment.
• Manage day-to-day investigations including OOT and OOS.
• Develop and approve methods, protocols, and reports for validation and stability studies.
• Lead, train, and mentor QC staff.

Skills

FDA regulations

Detail-oriented

Written & verbal communication

Leadership

Regulatory compliance

Problem solving

Team management

Adaptability

Education

Bachelor’s degree in Chemistry or related

5+ years QC Chemistry / R&D

Experience with cGMP documentation

Tools

HPLC

GC

Mass spectrometry

Job description

Nephron Pharmaceuticals in West Columbia, SC, is seeking a senior leader to oversee the QC Chemistry Laboratory. The role ensures FDA and DEA compliance, drives process improvements to reduce lead times, and maintains quality across testing, data integrity, and documentation.

You will recruit, train, and mentor staff while coordinating with Quality and Production to meet regulatory expectations and product release standards.