~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!

Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com

Ready to work with/through Magnit at Novartis? Please read on...
Batch Record Coordinator

Responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.
• MES/SAP/LIMS Super User to include floor support and training.
• SPOC for Batch Record Process includes creating reports; production terminating and approving records; issue resolution.
• Reviews all batch documentation for accuracy and completeness according to cGMP’s to ensure timely release.
• Ensures deviations are initiated for any batch record review related events Find/communicate deviations to QA /help with investigation
• Adheres to internal/external guidelines, specifications and regulatory requirements while reviewing batch documentation.
• Ensures all GMP’s, Work Procedures and SOP’s are followed.
• Positively interacts with internal associates to quickly and effectively resolve batch record documentation related issues.
• Addresses deficiencies and ensures completion of all follow-up actions, specifically those that target process fixes to maintain consistent resolutions to all batch review issues according to GMP standards and Novartis objectives.
• Within MES, is responsible for TECO all Manufacturing orders.
• Provide periodic updates at Manufacturing Team meetings to review current batch record errors to improve performance.
• Maintains strong collaborative relations with the Quality Group
• Maintain and follow CGTDM procedures for MBR creation, issuance, receipt, reconciliation, filing and archiving
• Print and issue batch records, in-process labels, and final product labels to support operations. 
• Issue labeling/tags for Apheresis through packaging of final product labelling to QA/Operations.

Education: 
BS degree or equivalent pharmaceutical experience. 
Strong background in Good Documentation Practices (GDP)

Languages: 
Fluent in speaking / writing in English

Experience:
• 1 -3 years experience in a regulated cGMP Environment. Strong aseptic manufacturing knowledge preferred

Other Qualifications:
• 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
• Alternate shifts, weekends and overtime will be required

Values & Behaviors:
• Strong sense of ownership and accountability
• Ability to adapt and learn new systems
• Ability to collaborate with other groups, teams and departments in addressing inventory related issues
• Speak Up Mentality
• Demonstrate a high level of discipline and self-motivation
• Maintains composure during stressful situations
• Promotes a positive can-do attitude
• Provides innovative solutions to complex or process improvement issues.

Location: Morris Plains, NJ(Onsite)
1 role is for Friday - Monday shift at 6am  ~~OR~~ 1 role is for Wed. - Saturday shift at 6am
Pay Rate: $35.46 - $42.31/hr based on experience and qualifications (W2 Only)
Contract: Approx 5-month 
Health, dental, vision, 401k

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?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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.

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourceproteam@prounlimited.com.