Pharma Sample Management Lead

Novo Nordisk A/S; Durham, Northern (NC, KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Parental leave

Family medical leave

Tuition Assistance

Life Insurance

Disability Insurance

Employee Referral Bonus

Job summary

Novo Nordisk A/S in Durham, NC seeks a Sampling Coordinator to oversee sampling activities within Bulk Manufacturing. You will manage sample inventory, liaise with QC/QA/MDev, and ensure regulatory compliance across production operations.

Responsibilities include creating sampling plans in LIMs, coordinating IPC testing, optimizing resources, and maintaining 5S standards. Strong MS Office, LIMS, and PAS-X proficiency are required.

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
• 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

Responsibilities

• 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

Skills

Microsoft Office

LIMS

PAS-X

4P Trainer

Communication

Education

Associate's degree

Tools

LIMS system

PAS-X

Microsoft Office

Job description

Novo Nordisk A/S in Durham, NC seeks a Sampling Coordinator to oversee sampling activities within Bulk Manufacturing. You will manage sample inventory, liaise with QC/QA/MDev, and ensure regulatory compliance across production operations.

Responsibilities include creating sampling plans in LIMs, coordinating IPC testing, optimizing resources, and maintaining 5S standards. Strong MS Office, LIMS, and PAS-X proficiency are required.