Sample Management Coordinator - SDF

Novo Nordisk • Durham, NC

20h • Onsite

About The Position

The Sample Management Coordinator - SDF position is responsible for coordinating and overseeing all sampling activities within the Bulk Manufacturing area. This role involves maintaining sample inventory, ensuring all Bulk manufacturing sample requirements are met, and serving as the primary point of contact between Bulk, QC, QA, and MDev regarding sampling activities. The position also supports daily activities of a cGMP production operation, including inspection, sampling, shelf-life expiry inventory, Job Instructions (JI), and regulatory compliance.

Requirements

• 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

Nice To Haves

• CLean 1 Star a plus

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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree