Job Description

QA Batch Release Specialist

The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy starting materials manufactured, packaged, and tested in compliance with current GMP regulations, procedures, and quality systems. Location: Indianapolis, IN LI-#onsite Shift: This position involves shift work which will be defined through site start up and commercialization readiness. This position involves on-call shifts, if required, when scheduled. 2 positions available

Key Responsibilities:

• During project startup, supports the qualification, validation, and operational readiness of the ongoing expansion in Indianapolis Isotopes manufacturing site.
• As the project progresses, this role will transition to perform release of all manufactured, packaged, and tested materials including but not limited to raw materials, intermediates, and finished API starting materials. 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)
• Support QA Operations by providing shopfloor quality oversight of production, quality control and supply chain departments to ensure adherence to cGMPs, including data integrity.
• During the initial project expansion project phase, the role will be in daytime. The role will move to shift work once qualification and validation activities start and during the operational manufacturing once the site is approved.

Essential Requirements:

• 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.

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 $81,200.00 - $150,800.00

Skills Desired Continued Learning, Dealing With Ambiguity, GMP Procedures, QA (Quality Assurance), Quality Control (QC) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

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