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.
The Manufacturing Batch Record Coordinator is located in Morris Plains, NJ and is responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.
Your responsibilities include, but are not limited to:
The Manufacturing Batch Record Coordinator is located in Morris Plains, NJ and is responsible for life cycle management of issued labels and documentation as well as the timely and effective GMP review of production records.
Your responsibilities include, but are not limited to:
- 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.
EEO Statement
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Minimum requirements
- Bachelor’s degree is highly preferred
- High school diploma is required with at least 1 year of GDP experience in lieu of Bachelor’s degree would be considered
- A minimum of 1 year of experience in a regulated GMP environment
- Strong background in Good Documentation Practices (GDP)
- Strong aseptic manufacturing knowledge preferred
- SAP and MES experience is preferred
- Quality experience is preferred
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@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.
The pay range for this position at commencement of employment is expected to be between $66,000 and $99,000 per year per year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. 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.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Customer-facing roles only:
While Novartis does not require vaccination for Covid-19 or proof of a recent negative test result for Covid-19 at this time, employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send
Division
Operations
Business Unit
CELL & GENE THERAPY
Country
USA
Work Location
Morris Plains, NJ
Company/Legal Entity
Novartis Pharmaceuticals
Functional Area
Technical Operations
Job Type
Full Time
Employment Type
Regular
Shift Work
Yes
Early Talent
Yes
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