Operations Sampling Technician I

Novo Nordisk • Clayton, NC

4d • Onsite

About The Position

Support all daily activities of a cGMP warehouse operation including inspection, sampling, sample management, shelf-life expiry inventory, Job Instructions (JI) & regulatory compliance. Relationships Reports to Manager Essential Functions Package samples for transport Follow Standard Operating Procedures in performance of assigned duties Support GMP Laboratory and Environmental Compliance through daily tasks and ensure compliance with training programs related to job functions Partner with QC, QA, EM & support groups to ensure raw material release for production & resources to support schedules and enable the process to run optimally Maintain CNC areas & performing routine cleanings and batch turnover Complete all paperwork in a cGMP compliant manner Participate in Systematic Problem Solving, cLEAN Mindset, and streamlining processes Support validation & project activities as required Sampling of Raw Materials from Bulk tankers, Pressurized Containers, IBC’s, drums & Palletized Material Ensure all errors are addressed & corrected real time ensuring compliance with cGMPs Record logbook entries & other associated forms/paperwork for the team Follow all safety & environmental requirements in the performance of duties Other duties as assigned Physical Requirements Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. Routinely operates & inspects manufacturing equipment using hands. Ability to do close precision work with their hands. Strap & unstrap pallets using hands. Must be able to remain in a stationary position (sitting and standing) 50% of the time. May require 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. Handles transport of hazardous materials. Occasionally performs critical job functions in extremely cold work environments. Ability to work in loud noise environments with hearing protection. Able to pass a driving exam for powered industrial trucks. Does not require a valid driver’s license.

Requirements

• High School Diploma or equivalent with a minimum of one (1) year of experience operating in a GMP regulated environment required
• Basic laboratory, sampling aseptic & ID testing techniques required
• Ability to read, write & understand product documentation & standard operating procedures with attention to detail & computer literacy required

Nice To Haves

• Associate’s degree in science or relevant field of study from an accredited university preferred
• BioWorks Certification preferred
• Knowledge of US, EU regulations & guidelines in reference to classified areas, sampling plans & methods & application of GMP’s a plus
• Ability to communicate technical information clearly in writing & presentations preferred
• Demonstrated experience in practical problem solving & process improvements a plus
• Experience in LIMS system a plus
• Experience planning, organizing, executing, checking results & revising work plans a plus

Responsibilities

• Package samples for transport
• Follow Standard Operating Procedures in performance of assigned duties
• Support GMP Laboratory and Environmental Compliance through daily tasks and ensure compliance with training programs related to job functions
• Partner with QC, QA, EM & support groups to ensure raw material release for production & resources to support schedules and enable the process to run optimally
• Maintain CNC areas & performing routine cleanings and batch turnover
• Complete all paperwork in a cGMP compliant manner
• Participate in Systematic Problem Solving, cLEAN Mindset, and streamlining processes
• Support validation & project activities as required
• Sampling of Raw Materials from Bulk tankers, Pressurized Containers, IBC’s, drums & Palletized Material
• Ensure all errors are addressed & corrected real time ensuring compliance with cGMPs
• Record logbook entries & other associated forms/paperwork for the team
• Follow all safety & environmental requirements in the performance of duties
• Other duties 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: Entry Level
• Education Level: High school or GED