Packaging Operations Lead (GMP & Quality)

RXinsider LTD.; West Columbia (SC); On-site; USD 60,000 - 80,000; Full time

Job summary

RXinsider LTD. seeks an experienced supervisor to oversee production machine operations and assist with related duties. You will ensure lines adhere to changeover timings, verify lot and expiration details, and maintain GMP-compliant records. You’ll train new hires and manage cross-training, plus monitor attendance to keep staffing aligned with production needs. Compliance with cGMP and FDA requirements is essential.

Qualifications

• Bachelor's degree or 5+ years equivalent experience in manufacturing.
• Previous manufacturing/production experience preferred.
• Ability to supervise and motivate up to 70 employees.

Responsibilities

• Communicate to/from peers via production log book and face-to-face with on-coming/off-going supervisor.
• Ensure lines run within time guidelines for changeovers with correct lot# and expiration date and product transfer.
• Verify all Batch Records and Lot Records meet GMP requirements including signatures/initials.
• Ensure training of new hires and cross-training personnel.
• Monitor attendance and timecards to ensure production staffing meets requirements.
• Perform administrative duties including personnel roster, scheduling, and line monitoring.
• Monitor production areas for adherence to cGMP, SOPs and safety regulations.
• Assist in developing solutions for chronic quality assurance problems.
• Report quality observations and regulatory issues to Quality Management.

Skills

Detail oriented

People supervision

Supervisory training

Communication

Change management

Integrity under pressure

Teamwork

Data accuracy

Education

Bachelor's degree or 5+ years equivalent experience

Job description

RXinsider LTD. seeks an experienced supervisor to oversee production machine operations and assist with related duties. You will ensure lines adhere to changeover timings, verify lot and expiration details, and maintain GMP-compliant records. You’ll train new hires and manage cross-training, plus monitor attendance to keep staffing aligned with production needs. Compliance with cGMP and FDA requirements is essential.