US-NC, Process Area Specialist - QC Job 461399200A0-MZ
|Requisition ID 54602BR|
Title Process Area Specialist - QC
Job Category Manufacturing
Job Description Position Purpose:
* Maintaining & making improvements to the Production Environmental Monitoring (PEMS) system including performing changes related to the Master Data.
* Perform investigations of EM Excursions.
* Completion of PEMS batch reports.
* Responsible for developing & performing training on aseptic concepts.
* Responsible for identifying aseptic process needs & improvement opportunities.
* Responsible for performing root cause analysis investigations for environmental excursions through use of SPS tools.
* Responsible for ensuring timely completion of EM investigations.
* Responsible for performing process confirmations to ensure compliance and process improvements.
* Responsible for generating PEMS reports to support batch release activities.
* Responsible for training on PEMS, aseptic concepts & EM sampling techniques.
* Responsible for ensuring department documents are current & standardized.
* Perform other duties as required.
Education: BS/BA in life sciences, engineering, computer science, or related field or equivalent combination of education & experience.
* 3+ years of aseptic manufacturing experience in a pharmaceutical environment.
* Environmental Monitoring experience preferred.
* Strong working knowledge of database management systems.
* Ability to read, write & understand standard operating procedures with attention to high-level concepts.
* Computer literacy.
* Ability to drive continuous improvements via Lean tools & Six Sigma methodologies.
* Knowledge of Aseptic conduct and behaviors in a pharmaceutical environment.
Organization/Planning: Proven expertise in planning/organizing, managing execution, checking results & revising plans.
Physical & Other Requirements:
* Ability to attain clean room gowning certification.
* Ability to work with hazardous materials including sanitants.
* Ability to work near operating equipment.
* Ability to travel internationally.
* Ability to work hours necessary to support production.
Department QC Environmental Monitoring Process
Position Location US - Clayton, NC
State/Provinces US - NC
Job/Position Country US
At Novo Nordisk, we know that driving change on a global level and improving treatment outcomes for people with diabetes and other chronic diseases begins here at home. That's why we make an unmatched commitment to our employees, our families and our communities. That means outstanding rewards, industry-leading training programs, and an environment that supports you to achieve your goals at every level. It's all part of the Novo Nordisk Way. It includes our Vision and our commitment to the Triple Bottom Line principle – helping us find the right balance between compassion and competitiveness
With a career at Novo Nordisk, you’ll feel a difference right from the start. It’s a sense of inspiration and mobility that comes from a shared belief in driving positive change for people, families, and communities everywhere. Congratulations on taking your first step!
Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Please visit our website at www.novonordisk.com