Sr. QA Specialist - Pharmaceutical Manufacturing
BioSpace · West Lebanon, NH · 2 wk ago
Quality AssuranceFull-time
About The Department
Site New Hampshire, located in West Lebanon, is where Novo Nordisk’s life-saving treatments are brought to life. Our manufacturing facility produces a global supply of our hemophilia and growth hormone product lines, as well as our next generation of cutting-edge medications. It’s not your average production site – it’s a tight-knit, supportive community working together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything we do.
Responsibilities
- Work together with the management team to set future quality direction
- Support the implementation of our ambitious goals by bringing the best practices from other Novo Nordisk sites
- Perform reviews/approvals of manufacturing and support documentation and records to certify compliance with in-house specifications/standards and GMP for all site biologics produced
- Have QA signature authority on the review of individual batch records, supporting test records and other ancillary support records
- Develop and coach QA colleagues as well as support manufacturing by being present on the manufacturing floor
- Help drive implementation of quality improvement projects, and support cross-functional projects across the site
Qualifications
- Bachelor’s Degree within a scientific or life science required
- Master’s Degree preferred
- Bachelor’s Degree with ten (10) years experience required
- Master’s Degree with eight (8) years experience preferred
- Six (6) years of direct QA experience preferred
Physical Requirements
- Local and International Travel: 0-5%
- Sitting most of the time with walking and standing required only occasionally
- Lift up to 10 pounds occasionally or constantly to lift, carry, push, pull or otherwise move objects
- Visual a to perform close activities such as: reading, writing, and analyzing