Specialist, Label Operations

Specialist, Label Operations – The Specialist supports site Label Control activities at the S12 Cell Therapy manufacturing facility in accordance with BMS policies, standards, procedures, and Global cGMPs. The role involves in‑process and drug product label printing, issuance of labels for manufacturing and packaging, and ensuring compliance with health authority requirements. Shift Available Sunday - Wednesday (with extended Wednesday off), 2nd Shift, 6:00 pm-6:30 am. Responsibilities Supports all activities for the Label Operations group. Issues clinical and commercial in‑process and final product labels for labeling operations. Ensures accurate printed information on labels in compliance with health authority requirements. Coordinates with production teams to ensure timely issuance of labels. Provides training on label operations and issuance requirements for internal personnel as needed. Writes, reviews and updates standard operating procedures (SOPs) related to job responsibilities. Supports new drug product launches, new market initiatives, and other quality management activities as assigned. Assists during internal and health authority inspections and audits of the facility. Participates in investigations, deviations, CAPA management, and other quality processes related to label control and issuance. Performs supplemental investigations and projects as required by management. Maintains current knowledge of GMPs and regulatory guidelines. Knowledge & Skills Knowledge and experience with GMP, quality, and compliance. Ability to write and review technical reports with clarity and brevity. Strong time‑management and independent work ethic. Good understanding of electronic document management and manufacturing execution systems. Advanced computer skills and a broadening technical knowledge base. Decision‑making ability for non‑routine issues. Recognition of quality opportunities and ability to propose solutions. Effective communication within the function and with cross‑functional teams. Ability to handle conflict and recommend resolutions to management. Preparation of accurate written communications and data reports. Ability to multitask and support inspections. Minimum Requirements B.S. degree required, minimum 2years relevant work experience. Equivalent combinations of education and experience are acceptable. Working Conditions Work performed in a typical office environment with standard office equipment. Seated work with occasional standing and walking (up to 10% of time). Requirement to carry or lift up to 30 pounds (15 kg) several times a day. Shift work may include day, evening, night, weekends, and holidays. Employees may perform additional duties as requested by management. Compensation Overview SummitWest –NJ –US: $34.92 - $42.32 per hour. The starting pay rate is based on job characteristics such as required skills, work location, and schedule. Eligible employees may receive additional incentive cash and stock opportunities. Benefits Health Coverage: Medical, pharmacy, dental, and vision care. Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, Employee Assistance Programs. Financial Well‑being and Protection: 401(k) plan, disability insurance, life insurance, accident insurance, supplemental health insurance, travel protection, personal liability protection, identity theft benefit, legal support, and survivor support. Paid Time Off: Flexible time off (unlimited) for exempt employees; paid vacation and holidays for non‑exempt employees; additional sick, volunteer, and leave options as applicable. #J-18808-Ljbffr