Stability Lab Coordinator - GMP & SAP Expert

System One; Clayton (NC); On-site; USD 39,000 - 41,000; Full time

Job summary

System One, Clayton, NC, is seeking a Laboratory Product Support professional for a 12-month onsite contract. You will manage stability sample inventory, maintain compliance documentation, coordinate testing activities, monitor stability chambers, and support GMP and quality initiatives.

Candidates typically hold a master’s or bachelor’s degree with relevant experience, with knowledge of ICH and GMP, SAP exposure, and familiarity with stability systems and related equipment.

Qualifications

• Master’s degree, or Bachelor’s degree with 1–2 years of relevant experience, or 5 years of relevant experience without a degree.
• Degree or experience in a scientific field or regulated pharmaceutical stability program.
• Knowledge of ICH guidelines, GMP requirements, stability sample handling, and biological sample shipment.
• Experience with stability databases, SAP, and regulated laboratory documentation.
• Experience with ScienTek Stability System, Loftware, Intermec printers, DeltaV, LabWatch, Maximo, TempTale, visual inspection, and vial integrity testing preferred.

Responsibilities

• Manage stability sample inventory, documentation, labeling, storage, and delivery for active stability studies.
• Coordinate sample acquisition, testing schedules, laboratory deliveries, and shipment of biological samples.
• Monitor stability chambers, analyze temperature and humidity trends, and support equipment maintenance and investigations.
• Maintain stability records, enter data into stability systems and SAP, and support GMP investigations and corrective actions.
• Generate work orders, purchase orders, and documentation to support stability program operations.

Skills

Stability program operations

Documentation management

Data entry SAP

Quality regulatory knowledge

Lab environment communication

Education

Master’s degree

Bachelor’s degree with 1–2 years relevant experience

5 years relevant experience without a degree

Tools

SAP

Stability System ScienTek

Loftware

Intermec printers

DeltaV

LabWatch

Maximo

TempTale

Job description

System One, Clayton, NC, is seeking a Laboratory Product Support professional for a 12-month onsite contract. You will manage stability sample inventory, maintain compliance documentation, coordinate testing activities, monitor stability chambers, and support GMP and quality initiatives.

Candidates typically hold a master’s or bachelor’s degree with relevant experience, with knowledge of ICH and GMP, SAP exposure, and familiarity with stability systems and related equipment.