Specialist, Label Operations

Shift Available

- Sunday–Wednesday (with e/o Wednesday off), 2nd Shift, 6:00pm–6:30am

• Support all Label Operations group activities.
• Issue clinical and commercial in-process and final product labels for labeling operations.
• Ensure label content accuracy and compliance with health authority requirements.
• Coordinate with production teams for timely label issuance.
• Train internal personnel on label operations and issuance requirements.
• Ensure SOPs define required steps; write, review, and update SOPs.
• Support new drug product launches, new markets, and other quality management activities.
• Support internal and health authority inspections/audits.
• Use knowledge of quality processes (label control/issuance, change control, complaints, deviations, investigations, CAPA).
• Perform supplemental investigations/projects as assigned.
• Maintain knowledge of current GMPs and regulatory guidelines.

• Knowledge/experience with GMP, Quality, and compliance.
• Ability to write/review technical reports; provide technical writing guidance.
• Understand electronic document management and manufacturing execution systems.
• Advanced computer skills; independent mindset; time organization.
• Confident decision-making for non-routine issues; recognize and act on quality opportunities.
• Communicate effectively with cross-functional teams; prepare accurate written communications.

B.S. degree required; minimum 2 years relevant work experience (or equivalent education/experience).

$34.92–$42.32 per hour (NJ, Summit West). Health, wellbeing, and financial benefits; paid time off.