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Quality Assurance Specialist
2 months ago
The Quality Operations Associate plays a critical role in ensuring the quality of products and processes at our Morris Plains site. As a first-level facilitator, you will work closely with site staff to implement quality strategies and drive continuous improvement.
Key Responsibilities:- Review and approve batch records, Apheresis, Aborted and Invalid Assays, etc. to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
- Conduct routine shop floor tasks related to aseptic operations, including ViMOS, APV program observations, walkthrough program, QA area release, etc.
- Perform triaging and initiation of events (Quality Event, Deviation, Action, CAPA, etc.) under the guidance of the Quality Assurance Manager.
- Actively engage in process improvement and Right First-Time initiatives at the Morris Plains site.
- Ensure adherence to appropriate regulations and Novartis quality standards.
- Write and/or review Standard Operating Procedures (SOPs), as needed.
- Assist in providing documentation for self-inspections and external audits.
- Champion a Quality Culture and ensure a safe working environment.
- BA degree in Biological Sciences or equivalent relevant career experience.
- A minimum of 2 years of experience in a pharmaceuticals environment.
- Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
- Excellent oral and written communication skills.
- Demonstrate ownership of completing daily tasks and excellent interpersonal skills.
- Ability to work under direction of team members, independently, and as part of a team if necessary.
Our purpose is to reimagine medicine to improve and extend people's lives. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
We are committed to building diverse teams, representative of the patients and communities we serve. If you are passionate about quality and excellence, and want to be part of a dynamic team, we encourage you to apply.
