Quality Assurance Label Control (QALC) Labeling Specialist - Pharma (Onsite-Summit, NJ) 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. Responsibilities 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. Requirements 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. #J-18808-Ljbffr Stage 4 Solutions
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