Quality Assurance Label Control (QALC) Labeling Specialist - Pharma (Onsite-Summit, NJ) - Stage 4 Solutions : Job Details

We are seeking a Quality Assurance Label Control (QALC) Labeling Specialist for a global pharmaceutical client. You will support the cGMP Label Control operations at the client site, including coordination, issuance, reconciliation, and management of production labels and records.

This is a 40-hour per-week, 6-month contract (extensions possible), 100% onsite role in Summit, NJ. The schedule is Wed-Sat (4pm- 2am) as 2nd shift. This is a W2 role as a Stage 4 Solutions employee, with health benefits and 401K offered.

• Support all activities for the Quality Assurance Label Control group.
• Issue clinical and commercial in-process and final product labels for labeling operations.
• Ensure accurate printed information on labels in compliance with health authority requirements.
• Coordinate with production teams for timely label issuance.
• Train internal personnel on label control and issuance requirements as needed.
• Write, review, and update SOPs related to job responsibilities.
• Support new drug product launches, market entries, and other quality activities as assigned.
• Assist during internal and health authority inspections and audits.
• Knowledge of quality processes including label control, change control, product complaints, deviations, investigations, and CAPA management.
• Perform supplemental investigations/projects as required by management.
• Maintain knowledge of current GMPs and regulatory guidelines.

• At least 2 years of relevant labeling experience in a cGMP/FDA regulated environment.
• Experience with label issuance, deviations, CAPA, SOP writing, project management, and a pharma background.
• Strong computer skills with MS Office (Word, Adobe, Visio, Excel) and Quality Systems (e.g., Document Management System, Quality Management System).
• Knowledge of manufacturing quality, including manufacturing, packaging, facilities, critical systems, validation.
• Crystal reports experience is preferred.
• Bachelor's degree required.

Please submit your resume via our website at and apply to the Quality Assurance Label Control (QALC) Labeling Specialist - Pharma (Onsite-Summit, NJ) role.

Feel free to share this opening with others who may be interested. Stage 4 Solutions is an equal-opportunity employer committed to diversity and inclusion. Employment decisions are based on qualifications and job requirements, without discrimination.

Compensation: $30/hr - $34.97/hr.