QC Chemistry Operations Lead

Nephron Pharmaceuticals Corporation; Columbia (SC); On-site; USD 85,000 - 115,000; Full time

Job summary

Nephron Pharmaceuticals Corporation is seeking a leader for the QC Chemistry Laboratory to oversee day-to-day operations within a fast-paced manufacturing environment. You will ensure compliance with FDA and DEA regulations, manage a team, and drive process improvements to shorten turnaround times while maintaining data integrity.

The role requires strong technical skills in HPLC, GC, mass spectrometry, and extensive experience with LIMS and cGMP systems.

Qualifications

• Minimum Bachelor’s degree and 5+ years in Quality Control Chemistry and/or R&D.
• Experience with cGMP documentation systems and quality control implementations.
• Preferred experience in analytical method development, transfer and validation.
• Strong experience in product QC testing and release procedures.

Responsibilities

• Plan, organize, and manage resources for sample testing to maintain workflow and schedules.
• Verify notebooks, raw data, and COAs before final QC approval.
• Verify data entry in LIMS conforms to product specifications.
• Provide management approval for final product release.
• Draft, edit, and approve SOPs for Analytical Services functions and equipment.
• Assist with laboratory investigations including OOT and OOS.

Skills

FDA regulations

Detail orientation

Communication skills

Leadership

HPLC

GC

Mass spectrometry

LIMS

Education

Bachelor's degree in science

5 years QC Chemistry experience

cGMP experience

Tools

Laboratory Information Management Systems (LIMS)

Job description

Nephron Pharmaceuticals Corporation is seeking a leader for the QC Chemistry Laboratory to oversee day-to-day operations within a fast-paced manufacturing environment. You will ensure compliance with FDA and DEA regulations, manage a team, and drive process improvements to shorten turnaround times while maintaining data integrity.

The role requires strong technical skills in HPLC, GC, mass spectrometry, and extensive experience with LIMS and cGMP systems.