QA Batch Release Technician

Job Description Summary

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).
• Other related duties as assigned.

Essential Requirements:

• Bachelors Degree preferably in Life Sciences chemistry or related relevant degree preferred.
• 1 years of experience in a GxP Biopharmaceutical manufacturing operations preferred with Bachelors degree
• 1 years of experience in a quality assurance role preferred with Bachelors degree
• In lieu of Bachelors Degree at least 5 years of relevant QA experience within pharmaceutical GMP QA considered.
• 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.

Novartis Compensation and Benefit Summary: The salary for this position is expected to range between $30.58/hr and $56.83/hr. 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 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 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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired