Manufacturing Operations Specialist
About The Position
365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives. The Manufacturing Operations Specialist is responsible for the dispensary / ISO8 area tasks including kitting and material flow, inventory management and other duties required to support the core functions. Job Description Location: Morris Plains, NJ - Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you. Shift: Sunday - Thursday 10 PM - 6:30 AM
Requirements
- 1-3 years of related experience in cGMP/FDA regulated industry.
- High School degree required.
- Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.
- Must be well organized, flexible and work with minimal supervision.
- Ability to lift up to 50 lbs., assisted.
- Requires handling of chemicals such as corrosives, solvents & bio-hazardous material
Nice To Haves
- Bachelor's degree preferred.
Responsibilities
- Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance.
- Ensure accurate SAP/MES inventories are maintained for all components.
- Ensure Manufacturing Support areas are maintained in an “audit ready” state.
- Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
- Escalate any observed compliance or safety issues and support reconciliation of event.
- Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
- Support monthly and annual cycle count and support all site/team projects and initiatives.
- Coordination of receiving, storage and processing of materials.
- Ensure inventory accuracy of GMP and non-GMP LN2 storage locations.
- Ensure accurate SAP/MES inventories are maintained for all components.
- Ensure proper status segregation and storage of all conditioned and ambient materials.
- Ensure Kanban system is accurate, and materials are consumed per FEFO/FIFO.
- Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production.
- Monitor staged kits for expired materials and to ensure utilization prior to expiry.
- Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels.
- Ensure dispensary area has ample supply of non-BOM items.
Benefits
- US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits.
- In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
Number of Employees
5,001-10,000 employees
