Quality Assurance Stability Associate

Quality Assurance Associate – Stability

Location: Totowa, NJ (Onsite)
Employment Type: Full-Time | Non-Exempt (Hourly)
Department: Quality Assurance
Reports To: QA-OTC Drug Stability Coordinator
Organizational Relationships: Works closely with the QA-OTC Drug Stability Coordinator and the Drug Stability Technician. Works with QA Systems & Compliance, QA Documentation, Validation, QC, Manufacturing, R&D, Process Engineering, Warehouse, Regulatory Affairs, Purchasing, external contract testing laboratories, and customer quality contacts as needed to support the stability program.

The QA Associate – Stability gives day-to-day quality assurance support to the QA-OTC Drug Stability Coordinator in running the site's OTC drug stability program, working alongside the Drug Stability Technician. You will maintain the stability schedule and pull calendar, coordinate sample storage, pulls and shipments to internal and external labs, support stability chamber monitoring and excursion documentation, and review and trend stability data.

You will also help with stability protocols and reports, support investigations into stability-related deviations and OOS/OOT results, and keep stability records complete and accurate. All work follows cGMP (21 CFR 210/211, including 211.166 and 211.137), ISO 22716, ICH stability principles and customer requirements, with a strong commitment to data integrity.

• Help maintain the master stability schedule, tracking study start dates, storage conditions and upcoming pull points (e.g., initial, 1, 2, 3, 6, 9, 12, 18, 24 and 36 months).
• Prepare and issue pull notices and work orders to QC and contract labs ahead of each pull date, and confirm pulls are completed within the allowable window.
• Support new study setup, including labeling, sample quantity checks, storage location assignment and creating study records under approved protocols.
• Maintain a tracker of active studies, pending pulls, testing status and reports due, and elevate at-risk or missed pull points.
• Coordinate with the Drug Stability Technician, Manufacturing, R&D and Regulatory Affairs on batch selection, packaging configurations and study requirements for commercial, new product and change-related studies.

• Perform and document stability sample pulls, chain of custody and shipments to internal and external labs.
• Maintain accurate sample inventory, including reconciliation and disposal of expired or completed study samples.
• Support daily chamber oversight: review temperature and humidity monitoring records, document alarms and excursions, and coordinate with Facilities and Engineering on chamber issues.
• Help document and assess the impact of chamber excursions and out-of-condition storage events, and track related corrective actions to closure.
• Track chamber qualification, mapping and calibration due dates and maintain the related records.

• Review stability results from QC and contract labs for completeness, accuracy and conformance to protocol specifications and time points.
• Enter, verify and trend stability data (e.g., assay, pH, viscosity, appearance, micro and preservative efficacy) in Excel or approved systems to spot shifts, trends and potential OOT results.
• Help prepare stability summary reports, shelf-life and expiration dating support, and customer stability data packages.
• Support drafting and revision of stability protocols, amendments and study summaries.
• Prepare stability metrics and status updates (e.g., on-time pull rate, testing turnaround, open investigations) for QA leadership.

• Flag potential OOS, OOT or unexpected results to…