Specialist, Label Operations
Bristol Myers Squibb
5 months 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 printed label information is accurate and compliant with health authority requirements.
- Coordinate with production teams to ensure timely label issuance.
- Train label operations/issuance requirements for internal personnel.
- Write, review, and update SOPs related to job responsibilities.
- Support new drug product launches, new market, and other quality management activities as assigned.
- Support internal and health authority inspections and audits.
- Apply knowledge of quality processes (label control/issuance, change control, product complaints, deviations, investigations, CAPA).
- Perform supplemental investigations/projects as required.
- Maintain knowledge of current GMPs and regulatory guidelines.
Knowledge & Skills (required unless marked preferred):
- Must have knowledge and experience with GMP, Quality, and compliance.
- Preferred: GMP/Quality/compliance experience.
- Write/review technical reports clearly and provide technical writing guidance.
- Moderate direction for complex tasks; perform routine tasks with little/no supervision.
- Time organized; independent mindset.
- Understand electronic document management and manufacturing execution systems.
- Advanced computer skills.
- Confident decisions for non-routine issues; recognize/address quality opportunities.
- Propose solutions for complex issues; communicate clearly; produce precise data reports.
- Multi-task; build cross-functional relationships and represent department as needed.
- Support internal and health authority inspections.
Minimum Requirements:
- B.S. degree required; minimum 2 years relevant work experience (or equivalent education/experience).
Working Conditions:
- Seated office work; standing/walking up to 10%.
- Lift/carry up to 30 lb (15 kg) several times/day.
- Must work assigned shift (including evenings/nights/weekends/holidays).
- 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 printed label information is accurate and compliant with health authority requirements.
- Coordinate with production teams to ensure timely label issuance.
- Train label operations/issuance requirements for internal personnel.
- Write, review, and update SOPs related to job responsibilities.
- Support new drug product launches, new market, and other quality management activities as assigned.
- Support internal and health authority inspections and audits.
- Apply knowledge of quality processes (label control/issuance, change control, product complaints, deviations, investigations, CAPA).
- Perform supplemental investigations/projects as required.
- Maintain knowledge of current GMPs and regulatory guidelines.
Knowledge & Skills (required unless marked preferred):
- Must have knowledge and experience with GMP, Quality, and compliance.
- Preferred: GMP/Quality/compliance experience.
- Write/review technical reports clearly and provide technical writing guidance.
- Moderate direction for complex tasks; perform routine tasks with little/no supervision.
- Time organized; independent mindset.
- Understand electronic document management and manufacturing execution systems.
- Advanced computer skills.
- Confident decisions for non-routine issues; recognize/address quality opportunities.
- Propose solutions for complex issues; communicate clearly; produce precise data reports.
- Multi-task; build cross-functional relationships and represent department as needed.
- Support internal and health authority inspections.
Minimum Requirements:
- B.S. degree required; minimum 2 years relevant work experience (or equivalent education/experience).
Working Conditions:
- Seated office work; standing/walking up to 10%.
- Lift/carry up to 30 lb (15 kg) several times/day.
- Must work assigned shift (including evenings/nights/weekends/holidays).