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Form of workThis 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...
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.
• 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)
• Other related duties as assigned.
Education & Qualification
Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree.
Experiences
5+ years of experience in a GxP Biopharmaceutical manufacturing operations
4+ years of experience in a quality assurance role
• Cross functional collaboration
• Functional Breadth
• 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.
Competencies
• Continuous Learning (Dyn. Knowledge Development)
• Digital & Technology Savvy
• Operational Excellence
• Being Resilient
• Breakthrough Analysis
• Interpersonal Savvy
• Organizational Savvy
Technical / Function Skills & Knowledge
• Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
• Knowledge of IT Applications & tools
• Quality Assurance
• Quality Control (QC) Testing
• Quality Standards
• Sterility Assurance and Aseptic Manufacturing
• Quality oriented with attention to details
• Strong organizational and time management skills
• Developed management and communication skills
Location: Indianapolis, IN (~~100% ONSITE~~)
QA Batch Release Specialist (Third shift - 22:00 (10PM) - 06:00 AM)
Pay Rate: $38 - $66/hour
Contract: 6 months
Health, dental, vision, 401k
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 we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine the impact you could make here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
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 or 1.862.778.5441.
Commitment to Diversity and Inclusion / EEO
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...
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.
• 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)
• Other related duties as assigned.
Education & Qualification
Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree.
Experiences
5+ years of experience in a GxP Biopharmaceutical manufacturing operations
4+ years of experience in a quality assurance role
• Cross functional collaboration
• Functional Breadth
• 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.
Competencies
• Continuous Learning (Dyn. Knowledge Development)
• Digital & Technology Savvy
• Operational Excellence
• Being Resilient
• Breakthrough Analysis
• Interpersonal Savvy
• Organizational Savvy
Technical / Function Skills & Knowledge
• Knowledge of GMP and regulations, including FDA regulations (21 CFR Parts 211, 212) and ICH
• Knowledge of IT Applications & tools
• Quality Assurance
• Quality Control (QC) Testing
• Quality Standards
• Sterility Assurance and Aseptic Manufacturing
• Quality oriented with attention to details
• Strong organizational and time management skills
• Developed management and communication skills
Location: Indianapolis, IN (~~100% ONSITE~~)
QA Batch Release Specialist (Third shift - 22:00 (10PM) - 06:00 AM)
Pay Rate: $38 - $66/hour
Contract: 6 months
Health, dental, vision, 401k
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 we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine the impact you could make here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
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 or 1.862.778.5441.
Commitment to Diversity and Inclusion / EEO
