Sample (Prep) Management Coordinator - OFP

4 weeks ago

Durham, North Carolina, United States Novo Nordisk Full time

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 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 Emerging Technologies - Oral Finished Products 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. OFP 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 holidaysHealth Insurance, Dental Insurance, Vision Insurance – effective day oneGuaranteed 8% 401K contribution plus individual company match optionFamily Focused Benefits including 12 weeks paid parental & 6 weeks paid family medical leaveFree access to Novo Nordisk-marketed pharmaceutical productsTuition AssistanceLife & Disability InsuranceEmployee 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 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 FunctionsManage 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 LIMSPartner with QC, QA, EM & support groups to ensure samples are handled as required by the approved protocolsSupports In process control (IPC) testing activities, during batch productionManage resources to support manufacturing schedules & ensure that the sample process functions optimallyCollaborates with QC Lab & MDev to ensure that sample requirements are metCoordinates & performs sample prep for lab, following production activitiesCoordinates & maintains in-process manufacturing sample inventoryMaintains supply inventory for sample prep (bottles, caps, vials, bags etc.)Set up & maintain 5S standards for Sample Management & storageSuggests & implements process improvement & standardization updatesExercise excellent communication skills to represent the departmentCoordinates requested sample shipments to Denmark, on an "as needed" basisPartner & collaborate closely with local colleaguesFollow Standard Operating Procedures in performance of assigned dutiesFollow all safety & environmental requirements in the performance of dutiesKnowledge of US regulations & guidelines in reference to sampling plans & methods & application of GMP'sOther accountabilities, as assignedPhysical Requirements Moves equipment &/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. May required corrected vision to 20/25 based on role. May require color vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials. QualificationsAssociate's degree in related field from an accredited university or an equivalent combination of education & experience requiredMinimum of five (5) years of experience in an administrative field, preferably in a pharmaceutical environment preferredMinimum of one (1) year of manufacturing experience in a pharmaceutical environment preferredAbility to problem solve & navigate complex assignments preferredStrong knowledge & experience using Microsoft Office applications including: Word, Excel, PowerPoint & Outlook requiredProficient knowledge (Static User) in LIMS system & PAS-X preferredExperienced in team training or Qualified 4P Trainer preferredClean 1 Star a plusStrong interpersonal, oral & written & communication skills, ability to efficiently communicate, both orally & in writing with peers & area management requiredDemonstrated experience in practical problem solving & process improvements preferredDemonstrates excellent organizational & planning skills with a high level of attention to detail requiredAvailable to work a 10 hr day shift hours Monday - Thursday We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

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