QA Batch Release Technican

Job Description Summary

About this role:

The QA Batch Release Technician 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 #LI-Onsite
Shift: 2nd, Friday-Tuesday

 

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 QA Batch Release as a valued business partner, with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.

• 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 preferred.  In lieu of degree, at least 5 years of relevant QA experience within pharmaceutical GMP QA considered. 

• 1+ years of experience in a GxP Biopharmaceutical manufacturing operations preferred with Bachelor’s degree.

• 1+ years of experience in a quality assurance role preferred with Bachelor’s degree.

• 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.

The pay range for this position at commencement of employment is expected to be between $59,900 and $89,900 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.

 

 You’ll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook:  https://www.novartis.com/careers/benefits-rewards

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

 

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