Sample Management Coordinator - SDF (Durham, NC, US)

Biopharma Careers

Durham, Northern (NC, KY)

Hybrid

USD 65,000 - 90,000

Full time

36 hours ago
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Job summary

Novo Nordisk in Durham, NC seeks a Sampling Coordinator to coordinate and oversee all sampling activities within the Bulk Manufacturing area, maintain sample inventory, and ensure compliance with cGMP production operations.

You will act as the primary contact between Bulk, QC, QA and MDev, supporting daily operations including inspection, shelf-life inventory, JI, and regulatory requirements.

Responsibilities

  • 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.

Job description

## About this opportunity**About the Department**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 positionsAll employees enjoy generous paid time off including **14 paid holidays**Health Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee Referral AwardsAt 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**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.**Relationships**Reports to Manager, Production OFP.**Essential Functions**Manage Sampling schedule, anticipate needs & effectively communicate with all stakeholdersCreate & implement sampling plans within LIMsReview protocols & other associated forms/paperwork for the team. Ensure all Parameters/Test Methods are correct when creating sample plans in LIMS
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