Sample Management Coordinator - SDF

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For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on 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 Emerging Technologies
-Solid Dosage Forms US facility in Durham, NC is a 194,000 square foot tableting and packaging facility that supports the production of our innovative oral treatments for patients with type 2 diabetes. SDF maintains a curious and pioneering spirit, harmonious with our growing pipeline of new products and emerging technologies.

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 14weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & 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.

Coordinate & oversee all sampling activities within the Bulk Manufacturing area. Maintain sample inventory & ensure that all Bulk manufacturing sample requirements are met. Function as primary point of contact between Bulk, QC, QA & MDev regarding Sampling Activities. Support all daily activities of a cGMP production operation including inspection, sampling, shelf-life expiry inventory, Job Instructions (JI) & regulatory compliance.

Reports to Manager, Production OFP.

• Manage Sampling schedule, anticipate needs & effectively communicate with all stakeholders
• Create & implement sampling plans within LIMs
• Review protocols & other associated forms/paperwork for the team. Ensure all Parameters/Test Methods are correct when creating sample plans in LIMS
• Partner with QC, QA, EM & support groups to ensure samples are handled as required by the approved protocols
• Supports In process control (IPC) testing activities, during batch production
• Manage resources to support manufacturing schedules & ensure that the sample process functions optimally
• Collaborates with QC Lab & MDev to ensure that sample requirements are met
• Coordinates & performs sample prep for lab, following production activities
• Coordinates & maintains in-process manufacturing sample inventory
• Maintains supply inventory for sample prep (bottles, caps, vials, bags etc.)
• Set up & maintain 5S standards for Sample Management & storage
• Suggests & implements process improvement & standardization updates
• Exercise excellent communication skills to represent the department
• Coordinates requested sample shipments to Denmark, on an “as needed” basis
• Partner & collaborate closely with local colleagues
• Follow Standard Operating Procedures in performance of assigned duties
• Follow all safety & environmental requirements in the performance of duties
• Knowledge of US regulations & guidelines in reference to sampling plans & methods & application of GMP’s
• Other accountabilities, as assigned

Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Ability to do close precision work with…