QA Batch Release Specialist

Band

Level 3

 

Job Description Summary

Help reimagine cancer care by shaping how our Radioligand Therapies (RLT) reach more patients—safely, reliably, and faster. At Novartis, we’re pioneering the future of treatment through the fusion of nuclear medicine and precision oncology.

The QA Batch Release Specialist is responsible for the quality assurance relea
se of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.

Location: Indianapolis, IN #LI-Onsite

Shift: Night Shift, weekend nights included

 

Job Description

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)

Essential Requirements:

• Bachelors' Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered

• 2+ years of experience in 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.

The salary for this position is expected to range between $81,200 and $150,800/year. 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.

 

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation t