QA CTO Label Specialist
On-site · Summit, New Jersey, United States
Job Summary
QA CTO Label Specialist onsite 2nd shift (Wed–Sat, 4pm–2am) responsible for issuing clinical and commercial in-process and final product labels, ensuring accuracy of printed information per health authority requirements, and coordinating with production. Maintains and trains on label control SOPs, supports new drug launches and quality management activities, and participates in inspections and CAPA. Requires a Bachelor’s degree with 2+ years in a cGMP/FDA environment, 1+ year labeling experience, strong MS Office and document management skills, and ability to work cross-functionally in a fast-paced manufacturing setting.
Required Qualifications
- Bachelor’s degree with 2+ years of experience in a cGMP/FDA regulated environment
- Minimum of 1 year of labeling experience in a cGMP/FDA regulated environment
- Some document management experience
- Crystal reports experience preferred
- Strong communication and customer service skills
- Strong computer skills with MS Office (Word, Visio, Excel) and Quality Systems
- Ability to develop and improve label issuance processes
- Project management skills
- Ability to work independently and with cross-functional teams
- Experience interacting with FDA or other regulatory agencies strongly preferred
- Strong knowledge of cGMPs and domestic regulatory requirements
- Knowledge of manufacturing quality (manufacturing, packaging, facilities, validation)
- Ability to write, review and update SOPs
- Ability to support internal and health authority inspections and audits
Apply with one swipe on Sorce. We auto-fill applications and apply on your behalf — no cover letters, no 40-minute forms.
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.