QC Stability Coordinator

Pine Pharmaceuticals•Town of Tonawanda, NY

About The Position

The Stability Coordinator is responsible for implementing and maintaining Pine Pharmaceuticals' stability study program, including equivalency, initial and recurring annual stability studies, in support of the Quality Control Department. This role owns the full lifecycle of stability testing operations, from sample accessioning and time point allocation through pulling, data delivery, reporting, and trending, ensuring each step is executed on schedule and in accordance with approved protocols, procedures, and applicable ICH guidelines. The Coordinator generates and maintains stability SOPs, protocols, and summary reports (interim and final), manages stability projects within the ERP system, and maintains sample inventory while coordinating submissions both internally and with external partners. This position also serves as a key point of communication for the stability program, publishing the monthly stability pull dashboard, supporting chamber organization, and reviewing test results to identify and help investigate out-of-trend or out of specification findings. Success in this role requires close collaboration with QC analysts, QA, and other departments to support investigations, management review, and regulatory audits, while maintaining strict compliance with cGMP and safety requirements. The Stability Coordinator is expected to manage multiple concurrent projects, contribute to continuous quality improvement initiatives, and uphold the data integrity and reliability of the stability program as it relates to product quality and regulatory compliance.

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.
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.

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.