Summary
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.
This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
Shift: 2nd (3 positions)
#Onsite
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.
About the Role
Key Responsibilities:
- Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance.
- 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 and ensure proper status segregation and storage of all conditioned and ambient materials.
- Ensure inventory accuracy of GMP and non-GMP LN2 storage locations
- Ensure accurate SAP/MES inventories are maintained for all components.
- 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 and 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 and ensure dispensary area has ample supply of non-BOM items.
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Essential Requirements:
- High School Degree or GED equivalent; Bachelor's degree preferred
- At least 1 year of related experience in cGMP/FDA regulated industry required
- SAP knowledge preferred
- Must be well organized, flexible and work with minimal supervision.
- Ability to lift up to 50 lbs.
- Alternate shifts, weekends and overtime will be required
- Requires handling of chemicals such as corrosives, solvents & bio-hazardous materials
The pay range for this position at commencement of employment is expected to be bbetween $28.79 and $43.22 per hour ; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Division
Operations
Business Unit
Innovative Medicines
Location
USA
Site
Morris Plains
Company / Legal Entity
U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No