Stability Lab Coordinator I: Data, Protocols & Compliance

Alcami Corporation; Kirkland (NC); On-site; USD 45,000 - 60,000; Full time

Job summary

Alcami Corporation is seeking a Stability Coordinator I to drive stability programs and manage project logs for laboratory testing. You will handle protocol generation, sample receipt, inventory, and transfer/shipment while ensuring accurate electronic records and up-to-date files for client programs.

The role emphasizes cGMP compliance, safety training, and cross-department collaboration, with on-site duties and standard day shift expectations. DEA documentation support may be required.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences or related field preferred.
• 0–2+ years of related experience or 4+ years with a high school diploma.
• Prior cGMP experience preferred and laboratory/documentation background.

Responsibilities

• Log in and generate projects for laboratory testing and stability campaigns.
• Maintain stability storage protocols and revisions in electronic systems.
• Generate and review stability storage protocols including schedules and testing.
• Receive samples for stability storage and initiate chain-of-custody tracking.
• Prepare samples for internal and external shipments.
• Support client notification for sample destruction and disposition.
• Assist with DEA Form 222 and related documented controls per policies.
• Respond to environmental monitoring for stability chambers.
• Maintain stability inventory and perform routine reviews.
• Ensure documentation is accurate, complete, and compliant with safety and training requirements.

Skills

Attention to detail

Multi-tasking

Microsoft Office

Lab documentation

Communication skills

Education

Bachelor's degree in Pharmaceutical Sciences

High school or GED with related experience

Tools

LIMS software

Electronic record systems

Job description

Alcami Corporation is seeking a Stability Coordinator I to drive stability programs and manage project logs for laboratory testing. You will handle protocol generation, sample receipt, inventory, and transfer/shipment while ensuring accurate electronic records and up-to-date files for client programs.

The role emphasizes cGMP compliance, safety training, and cross-department collaboration, with on-site duties and standard day shift expectations. DEA documentation support may be required.