Quality-Focused GMP Sampling Technician I

Novo Nordisk; Clayton (NC); On-site; USD 42,000 - 52,000; Full time

Benefits offered by this job

Health insurance

Paid time off

401K with company match

Job summary

Novo Nordisk in Clayton, NC seeks a motivated warehouse operator to support daily cGMP activities, sampling, and material handling. You will follow SOPs, assist in QA/QC tasks, and ensure compliance with training on cGMPs while coordinating with QC/QA teams to release materials for production.

Ideal candidates have GMP experience and a science background, with strong attention to detail, good computer skills, and a readiness to participate in improving processes and safety programs.

Qualifications

• High School Diploma or equivalent with a minimum of one year of experience operating in a GMP regulated environment required
• Associate’s degree in science or relevant field of study from an accredited university preferred
• BioWorks Certification preferred
• 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
• 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 plusExperience 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, lean 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

Skills

Attention to detail

Computer literacy

Technical communication

Education

High School Diploma or equivalent

Associates degree in science

BioWorks Certification

Tools

LIMS

Job description

Novo Nordisk in Clayton, NC seeks a motivated warehouse operator to support daily cGMP activities, sampling, and material handling. You will follow SOPs, assist in QA/QC tasks, and ensure compliance with training on cGMPs while coordinating with QC/QA teams to release materials for production.

Ideal candidates have GMP experience and a science background, with strong attention to detail, good computer skills, and a readiness to participate in improving processes and safety programs.