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GuruNanda LLC
Quality Assurance Stability Supervisor
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What they do
A Quality Assurance Supervisor supervises quality assurance staff and oversees processes involved in the prevention of faults in manufactured products and solutions.
$83,479 / year median in California
-1% projected decline
Job Description
Overview The QA Stability Supervisor manages the site's stability program for OTC drug products, overseeing stability study design, chamber operations, sample pull scheduling, data trending, and reporting in support of product shelf-life claims and regulatory commitments. This role supervises stability coordination staff and ensures the program operates in full compliance with ICH Q1A guidelines and 21 CFR 211.166. Responsibilities Own and manage the site Stability Program, including protocol development, study initiation, and maintenance of ongoing stability studies (long-term, accelerated, intermediate, and in-use) per ICH Q1A(R2) and 21 CFR 211.166. Supervise stability coordination staff responsible for sample pulls, chamber loading/unloading, and sample submission to QC laboratories; assign and review daily/weekly workload. Maintain the stability chamber qualification and monitoring program, including mapping, calibration schedules, and excursion/deviation response for temperature and humidity chambers. Review and trend stability data (assay, dissolution, impurities, microbial, physical attributes) to identify adverse trends, out-of-trend (OOT) results, and potential shelf-life or specification concerns. Prepare, review, and approve annual stability summary reports, stability protocols, and stability sections of regulatory submissions and annual product reviews (APR)/product quality reviews (PQR). Coordinate with R&D and Regulatory Affairs on stability study design for new products, formulation changes, packaging changes, and site transfers, ensuring bracketing/matrixing designs meet regulatory expectations where applicable. Manage the stability sample inventory and chain-of-custody, ensuring samples are stored, tracked, and pulled per approved protocols and timelines. Investigate and document stability-related deviations, OOS/OOT results, and chamber excursions in partnership with QC and QA; drive CAPAs to closure. Support internal and external audits/inspections by presenting the stability program, data, and supporting documentation. Maintain stability program SOPs and ensure staff training/competency on stability procedures, sample handling, and data integrity requirements. Track and report stability program metrics (on-time pulls, chamber uptime, study status) to QA leadership. Qualifications Bachelor's degree in Chemistry, Pharmaceutical Sciences, Microbiology, or related scientific field. 5-7 years of experience in a stability, Quality Assurance, or Quality Control role within OTC pharmaceutical manufacturing; prior supervisory experience preferred. In-depth knowledge of ICH Q1A(R2) stability guidelines, 21 CFR 211.166, and USP compendial requirements as related to stability testing. Experience with stability management software (e.g., Stability System, LIMS-integrated stability modules) and chamber monitoring/BMS systems. Strong data trending, statistical analysis, and technical writing skills. Demonstrated leadership and team supervision skills; ability to manage competing priorities across multiple concurrent stability studies.