Manufacturing Batch Record Coordinator

Job Description Summary

The Manufacturing Batch Record Coordinator is responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.

Job Description

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.

This role is located on-site in Morris Plains, NJ. Novartis is unable to offer relocation support for this role. Please note the shift for this role is Wednesday through Saturday (6am - 4pm)

Major accountabilities :

• 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.

The salary for this position is expected to range between $23.99 and $44.56 per hour.

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

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.

Minimum Requirements :

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.

Accessibility and 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 us.reasonableaccommodations@novartis.com 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.

Salary Range

$49,900.00 - $92,700.00

Skills Desired

Assembly Language, Cooperation, Efficiency, Electronic Components, Flexibility, General Hse Knowledge , Good Documentation Practice, Installations (Computer Programs), Iso (International Organization For Standardization), Job Description, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Nuclear Medicine, Physics, Product Distribution, Production Line, Scheduler