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About the Role

The Stability Coordinator implements and maintains Pine Pharmaceuticals' stability study program, managing the full lifecycle of stability testing operations from sample accessioning to data reporting and trending. This role ensures compliance with protocols, procedures, and ICH guidelines, while collaborating with various departments to support investigations and audits.

Responsibilities

• Generate and support stability SOPs, protocols, and summary reports (interim and final).
• Ensure timely completion of stability time point pulls as required per applicable protocols and procedures.
• Manage projects within the ERP system for initial and annual stability studies.
• Maintain stability sample inventory and coordinate sample submissions, both internally and externally.
• Support product equivalency studies, including material risk assessments.
• Publish and disseminate the monthly stability pull dashboard to applicable groups and analysts.
• Ensure stability chamber organization and maintenance, and support troubleshooting.
• Support and assist with metrics for stability studies in support of investigations and management review.
• Review stability test results, identify out-of-trend results; support ongoing investigations.
• Ensure on-schedule data delivery for study time points per procedure.
• Support stability data trending in accordance with stability program SOPs and ICH guidelines.
• Ensure compliance with cGMP and safety requirements.
• Participate in continuous quality improvements.
• Support regulatory audits of the Quality Control Department.
• Perform other duties as determined to support the laboratory.

Requirements

• Bachelor's degree of science preferred.
• Relevant work experience in pharmaceutical manufacturing.
• 3-5 years of related work experience preferred in a laboratory environment or pharmaceutical environment.
• Experience with cGMP 21 CFR 11/210/211/820 Quality Systems.

Skills

• Excellent organizational, verbal, and written communication skills.
• Ability to effectively communicate with multiple levels within the organization.
• Ability to work on multiple projects simultaneously.
• Knowledge of International Conference on Harmonization (ICH) guidelines and current Good Manufacturing Practice (cGMP).
• Experience with Microsoft Office and LIMS preferred.

Experience Level

• 3-5 years of related work experience preferred

Education Level

• Bachelor's degree of science preferred