QA Label Control Specialist - Cell Therapy (GMP Manufacturing) 2nd shift
6 days ago
Summit
Job Description SOKOL GxP Services is seeking a QA Label Control Specialist (2nd Shift) to support our client’s Cell Therapy Manufacturing facility in Summit, NJ. In this role, you will execute label control, issuance, and printing activities to ensure compliance with FDA, cGMP, and internal quality standards for clinical and commercial cell therapy products. You will be responsible for preparing, verifying, and issuing in-process and final product labels, maintaining documentation accuracy, and supporting inspection readiness. This position collaborates closely with Manufacturing, Quality Assurance, Quality Control, and CTDO operations to ensure timely label delivery and error-free execution of GMP processes. This is an excellent opportunity for someone with hands-on labeling experience in a regulated biopharmaceutical environment, strong documentation discipline, and the ability to work independently on a fast-paced shift supporting patient-critical therapies. Requirements Education & Experience • Bachelor’s degree in a scientific discipline (Biology, Chemistry, or related field) – U.S. degree required, • 1+ years of labeling experience in a cGMP/FDA-regulated biopharma environment, • 1+ years of Quality experience, • 1+ years of U.S. biopharmaceutical manufacturing or QA operations experience, • 3+ years of experience using MS Office 365 (Excel, Teams, SharePoint in project/document control settings)Technical Skills, • Experience in label issuance, printing, verification, and reconciliation, • Familiarity with labeling systems; Crystal Reports or BarTender preferred, • Hands-on use of document management systems (e.g., Veeva, MasterControl, Documentum), • Understanding of change control, deviations, CAPA, investigations, and quality systems, • Ability to write, revise, and maintain SOPs, work instructions, and technical documentationCore Competencies, • Strong understanding of GMP, compliance, and data integrity, • High attention to detail and accuracy in all documentation, • Ability to recognize issues, escalate appropriately, and propose solutions, • Excellent communication and customer service mindset, • Ability to work independently on shift while collaborating with cross-functional teams, • Ability to support internal and health authority inspections through accurate documentation and retrieval, • Strong time-management skills with the ability to handle multiple priorities, • Advanced computer proficiency and comfort working within electronic systemsKey Responsibilities, • Issue and print clinical and commercial labels for manufacturing and packaging, • Ensure labels meet all regulatory and internal quality requirements, • Coordinate with production to support timely and accurate label availability, • Support document accuracy, label reconciliation, and tracking activities, • Maintain and update SOPs, label control procedures, and documentation, • Provide training for personnel on label issuance processes, • Support audits, inspections, and quality investigations as required Competitive hourly rate: $27.52 – $34.96/hr (W-2 only, no C2C). Working Hours: 2nd Shift , Wed-Sat - 4pm-2am. 6-month contract with possibility of extension or conversion for the right candidate depending on performance. Health insurance, holiday pay, 401(k) program, and other benefits. Employee referral bonus program.
