Senior Quality Assurance Area Specialist I
Clayton | Permanent | www.tiptopjob.com |
About the Department
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life:changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square:feet of state:of:the:art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products.
At API, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance : effective day one
• Guaranteed 8 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental and 6 weeks paid family medical leave
• Free access to Novo Nordisk:marketed pharmaceutical products
• Tuition Assistance
• Life and Disability Insurance
• Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Responsible for the production activities and validation. Ensures relevant compliance issues are addressed and handled in close collaboration with production. Main duties include review of batch reports and release of API materials, deviations, change controls, review and approval of SOPs, QA presence and process confirmation on shop floor and improvement of Quality processes.
Relationships
Reports to Manager, Quality Assurance.
Essential Functions
stylemargin:bottom:11.0px:
• Ensure that the current Novo Nordisk (NN) procedures and requirements from health authorities are reflected in the validation planning and quality related decisions
• Support validation projects in communicating Novo Nordisk project quality requirements and assessing suppliers' ability to support test/qualification activities to ensure that Novo Nordisk requirements and expectations are clear
stylelist:style:type:disc:
• Support projects in solving quality related issues, act quickly in order to come to a decision, and communicate quickly and clearly regarding such decisions
• Support evaluation of the quality level during the project by performing spot checks of validation documentation
• Perform activities related to Batch review and release
• Review and approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
• Ensure site compliance with Regulations, ISO standards, and Corporate/Local SOPs
• Review and approve change control requests
• Review and approve deviations
• guidance to departments regarding quality and related activities
• Participate and provide input to root:cause analysis
• Participate in process confirmations and quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned
Physical Requirements
stylemargin:bottom:11.0px:
• Moves equipment and /or supplies weighing up to 33 pounds within the facility using various body positions
• Ability to do close precision work with their hands
• Must be able to remain in a stationary position (sitting and standing) 50 of the time
stylelist:style:type:disc:
• May required corrected vision to 20/25 based on role
• May require color vision based on role
• Occ
At Novo Nordisk, we are helping to improve the quality of life for millions of people worldwide. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life:changing careers, and the opportunity to help improve the quality of life for millions of people around the world.
In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains. Our newer Active Pharmaceutical Ingredients (API) facility in Clayton, NC sits on 825,000 square:feet of state:of:the:art equipment, and houses the Fermentation, Recovery and Purification in the production of ingredients for Novo Nordisk's innovative oral products.
At API, you'll join a global network of manufacturing professionals who are passionate about what they do.
What we offer you:
• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance : effective day one
• Guaranteed 8 401K contribution plus individual company match option
• Family Focused Benefits including 12 weeks paid parental and 6 weeks paid family medical leave
• Free access to Novo Nordisk:marketed pharmaceutical products
• Tuition Assistance
• Life and Disability Insurance
• Employee Referral Awards
At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.
The Position
Responsible for the production activities and validation. Ensures relevant compliance issues are addressed and handled in close collaboration with production. Main duties include review of batch reports and release of API materials, deviations, change controls, review and approval of SOPs, QA presence and process confirmation on shop floor and improvement of Quality processes.
Relationships
Reports to Manager, Quality Assurance.
Essential Functions
stylemargin:bottom:11.0px:
• Ensure that the current Novo Nordisk (NN) procedures and requirements from health authorities are reflected in the validation planning and quality related decisions
• Support validation projects in communicating Novo Nordisk project quality requirements and assessing suppliers' ability to support test/qualification activities to ensure that Novo Nordisk requirements and expectations are clear
stylelist:style:type:disc:
• Support projects in solving quality related issues, act quickly in order to come to a decision, and communicate quickly and clearly regarding such decisions
• Support evaluation of the quality level during the project by performing spot checks of validation documentation
• Perform activities related to Batch review and release
• Review and approve API/Intermediate Batch documentation in various Novo Nordisk systems (e.g., LIMs, SAP, NovoGlow, etc.)
• Ensure site compliance with Regulations, ISO standards, and Corporate/Local SOPs
• Review and approve change control requests
• Review and approve deviations
• guidance to departments regarding quality and related activities
• Participate and provide input to root:cause analysis
• Participate in process confirmations and quality oversight
• Authorized person according to Novo Nordisk Quality Manual
• Other accountabilities, as assigned
Physical Requirements
stylemargin:bottom:11.0px:
• Moves equipment and /or supplies weighing up to 33 pounds within the facility using various body positions
• Ability to do close precision work with their hands
• Must be able to remain in a stationary position (sitting and standing) 50 of the time
stylelist:style:type:disc:
• May required corrected vision to 20/25 based on role
• May require color vision based on role
• Occ
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