Job Description Summary

The Specialist Quality Assurance is responsible for ensuring the highest level of quality and compliance in the manufacturing process. This role will collaborate with cross-functional teams and external partners to identify areas of improvement, implement quality assurance measures, and evaluate the effectiveness of manufacturing processes. The Sr. Specialist, Quality Assurance will also lead investigations into product non-conformance and provide guidance on corrective actions to ensure compliance with regulatory standards.

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

Job Description

Major accountabilities:

Makes quality decisions, addressing and resolving issues based on written procedures and analysis.
Communicates batch record review status and issues effectively and promptly to quality and manufacturing.
Performs batch record review on the manufacturing shop floor consistently.
Ensures the conformance of the manufacturing and packaging processes to cGMP, policies and procedures.
Direct support of fill finish production material.
Review and approve manufacturing batch records logbooks and associated documentation and quality records such as deviations, investigations, DCEs, CAPAs and Change Controls.
Partners with cross-functional teams to resolve documentation and batch related issues.
Provides cGMP observations to management and escalates issues and challenges as needed.
Provides critical quality expertise to quality and manufacturing supporting 24/7 operations.
Other related duties as assigned.

Minimum Requirements:

Bachelor's degree required in Chemistry, Biochemistry or similar technical disciplines or related field with 3 years of experience; or Associates degree with 5 years' experience in pharmaceutical-based GMP manufacturing operations including direct experience in documentation review.
Previous experience with viral gene therapies and/or orphan disease indications is a plus.
Knowledge of clinical trials and commercial manufacturing. This individual must have a strong knowledge and application of the CFRs and cGMPs.
High level of accuracy and attention to detail.
Good written and verbal communication skills with the ability to convey information clearly and accurately.

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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, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and 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 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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

$97,600.00 - $146,400.00

Skills Desired

Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence