QA CTO Label Specialist

1 week ago

Summit, United States TSR Consulting Full time

Job Title: QA CTO Label Specialist Location: Summit, NJ 100% Onsite Shift: 2nd Shift Wednesday to Saturday, 4:00 PM 2:00 AM Positions: 2 Position Overview The Label Control Specialist at the S-12 Cell Therapy Manufacturing Facility will support all site label control activities in alignment with company policies, procedures, standards, and global cGMP requirements. This role is essential in supporting in-process and drug product label printing, ensuring the accurate and timely issuance of labels used for manufacturing and packaging within Cell Therapy Development and Operations (CTDO). The Label Control organization plays a critical role in establishing, maintaining, and continuously improving the clinical and commercial label control processes and ensuring compliance, patient safety, and operational excellence. Key Responsibilities Support daily operations within the Label Control group. Issue clinical and commercial in-process and final product labels for labeling activities. Verify accuracy of printed information on labels in alignment with all health authority requirements. Coordinate with production teams to ensure timely label issuance. Provide training to internal personnel on label control processes as needed. Write, review, and update SOPs related to label control and issuance. Support new product launches, market expansions, and other quality management activities. Assist during internal and health authority inspections/audits. Support investigations, deviations, change controls, product complaints, and CAPA activities. Conduct supplemental projects and investigations as assigned by management. Maintain up-to-date knowledge of current GMPs and relevant regulatory guidelines. Required Competencies & Skills Strong working knowledge of GMP, Quality, and Compliance. Ability to write and review technical reports with clarity and brevity. Ability to work independently with minimal supervision. Strong organizational skills and ability to multitask. Proficiency in electronic document management and manufacturing execution systems. Advanced computer skills to enhance departmental productivity. Sound decision-making abilities for non-routine issues. Strong communication skills; able to collaborate across cross-functional teams. Capability to recognize issues, propose solutions, and work with leadership toward resolution. Ability to generate precise data reports and documentation. Ability to support internal and external inspections. Education & Experience Bachelor’s degree required Minimum 2 years of relevant industry experience

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