What are the responsibilities and job description for the Sample Management Coordinator - SDF position at BioSpace?
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 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 14 weeks 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.
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 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
Physical 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 colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.
Qualifications
Associate's degree in related field from an accredited university or an equivalent combination of education & experience required
Minimum of five (5) years of experience in an administrative field, preferably in a pharmaceutical environment preferred
Minimum of one (1) year of manufacturing experience in a pharmaceutical environment preferred
Ability to problem solve & navigate complex assignments preferred
Strong knowledge & experience using Microsoft Office applications including: Word, Excel, PowerPoint & Outlook required
Proficient knowledge (Static User) in LIMS system & PAS-X preferred
Experienced In Team Training Or Qualified 4P Trainer Preferred
CLean 1 Star a plus
Strong interpersonal, oral & written & communication skills, ability to efficiently communicate, both orally & in writing with peers & area management required
Demonstrated experience in practical problem solving & process improvements preferred
Demonstrates excellent organizational & planning skills with a high level of attention to detail required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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 14 weeks 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.
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 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
Physical 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 colour vision based on role. Occasionally ascends/descends a ladder. May be required to work at elevated heights. Occasionally works around odorous &/or hazardous materials.
Qualifications
Associate's degree in related field from an accredited university or an equivalent combination of education & experience required
Minimum of five (5) years of experience in an administrative field, preferably in a pharmaceutical environment preferred
Minimum of one (1) year of manufacturing experience in a pharmaceutical environment preferred
Ability to problem solve & navigate complex assignments preferred
Strong knowledge & experience using Microsoft Office applications including: Word, Excel, PowerPoint & Outlook required
Proficient knowledge (Static User) in LIMS system & PAS-X preferred
Experienced In Team Training Or Qualified 4P Trainer Preferred
CLean 1 Star a plus
Strong interpersonal, oral & written & communication skills, ability to efficiently communicate, both orally & in writing with peers & area management required
Demonstrated experience in practical problem solving & process improvements preferred
Demonstrates excellent organizational & planning skills with a high level of attention to detail required
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.
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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.