Specialist I, QA (Manufacturing)
A health care company with global reach. A product pipeline filled to the brim. A team committed to scientific advancement.
Think what's possible.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field.
Job Purpose:
To support the development and maintenance of quality procedures, batch records, and systems related to Quality Assurance oversight of manufacturing processes.
To provide strategic and technical support for the US FCC site in all cGMP compliance related matters, including assurance that all aspects of manufacturing comply with cGMPs, legal, regulatory requirements, and the Novartis VD Quality Manual requirements.
Accountabilities:
• Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products at the site comply with the requirements of the Novartis Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
• Maintain the quality systems related to Quality Assurance for in-process sampling and control, and all aspects of Shop floor QA for the USFCC facility, in compliance with cGMPs and the Novartis VD Quality manual.
• Perform batch record review concurrent to completion of manufacturing operations, in real time.
• Assess and approve minor deviations in real time.
• Perform routine quality audits of both Manufacturing and QC laboratory environments, equipment, and procedures, with approximately 50-75% of the typical workday spent in the manufacturing suites.
• Participate as the QA representative on multi-functional continuous improvement (lean, six sigma, issue resolution, etc.) teams.
• Acquire and maintain knowledge of current local and international regulatory and legislative requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
• Assist with the timely implementation of safety, security, industrial hygiene and ecology regulations in all parts of the site.
• Bachelor's Degree in the field of Microbiology, Chemistry, Biotechnology, Biochemistry, or Pharmacy or related degree
• Minimum of 5 years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry.
• Sterile product manufacturing knowledge a plus.
• Biopharmaceutical experience a plus.
