What are the responsibilities and job description for the QA Batch Release Specialist position at Novartis?
Summary
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
Location: Indianapolis, IN
Shift: 2nd shift- Wednesday- Sunday 2:30pm-11:00pm
About The Role
Key Responsibilities:
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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. 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 & 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.
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
Location: Indianapolis, IN
Shift: 2nd shift- Wednesday- Sunday 2:30pm-11:00pm
About The Role
Key Responsibilities:
- Perform release of all manufactured, packaged and tested materials including but not limited to raw materials, intermediates and drug products. Confirm all documentation supporting these releases fully adhere to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
- Controlled issuance of batch records in preparation for manufacturing.
- Perform review of manufacturing batch records in preparation for batch release and escalate any discrepancies immediately.
- Assist functional areas with achieving timely and compliant final product disposition of the product.
- Ensure Specifications in place and are within GMP compliance
- Support metric tracking of documentation and release data to ensure continuous improvement.
- Support QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
- CAPA management as well as improving processes within QA Batch release
- Organize and file all executed and associated GMP documentation (e.g. batch records).
- Maintain batch documentation library (record check-in, check-out, follow-up, and distribution)
- Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 3-5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered
- 2 years of experience in a GxP Biopharmaceutical manufacturing operations
- 1 years of experience in a quality assurance role
- Cross functional collaboration
- QA and QC experience in biotech pharmaceutical biotechnology industry with environmental monitoring & cleanliness zones is desired
- Proven track record and practical experience with cGMP requirements
- Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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. 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 & 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.
Salary : $81,200 - $150,800
