Specialist, Label Operations
Bristol Myers Squibb
9 days ago
On-site
Summit, NJ
Operations
Shift Available:
- Sunday–Wednesday (with e/o Wednesday off), 2nd Shift, 6:00pm–6:30am
Responsibilities:
- 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 & Skills / Qualifications (preferred & required):
- 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.
Minimum Requirements:
- B.S. degree required; minimum 2 years relevant work experience (or equivalent education/experience).
Compensation/Benefits (as stated):
- $34.92–$42.32 per hour (NJ, Summit West). Health, wellbeing, and financial benefits; paid time off.
- Sunday–Wednesday (with e/o Wednesday off), 2nd Shift, 6:00pm–6:30am
Responsibilities:
- 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 & Skills / Qualifications (preferred & required):
- 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.
Minimum Requirements:
- B.S. degree required; minimum 2 years relevant work experience (or equivalent education/experience).
Compensation/Benefits (as stated):
- $34.92–$42.32 per hour (NJ, Summit West). Health, wellbeing, and financial benefits; paid time off.