Stability Administrator

Title: Stability Administrator Location: Bedford, Ohio Job Type: Full-Time We are seeking a talented and motivated Stability Administrator to join our team. In this role, you will be responsible for coordinating and maintaining stability programs supporting oral and sterile injectable products. This role ensures that all stability studies are executed in compliance with ICH guidelines, FDA regulations, and cGMP requirements, supporting Hikma’s commitment to delivering high‑quality, affordable medicines globally. The position plays a key role in sample lifecycle management, data integrity, and inspection readiness, particularly within regulated, FDA‑inspected manufacturing environments. Key Responsibilities Stability Program Coordination Manage stability programs in accordance with ICH Q1A(R2) and Hikma procedures. Maintain stability schedules for commercial products, validation batches, and stability commitments. Coordinate sample pulls and testing timelines (e.g., 0, 3, 6, 12, 24, 36 months). Ensure alignment with regulatory commitments (ANDA/NDA submissions) . Sample Management & Stability Chambers Oversee receiving, labeling, storage, and tracking of stability samples. Manage stability chambers under controlled conditions: Long‑term, intermediate, and accelerated conditions Monitor chamber performance (temperature/humidity) and escalate excursions. Maintain inventory and traceability of samples in compliance with data integrity standards . Documentation & Data Integrity Maintain stability protocols, reports, and logs in compliance with: cGMP (21 CFR Part 210/211) ICH guidelines Ensure adherence to ALCOA+ principles for all stability data. Enter and verify data in electronic systems (e.g., LIMS, TrackWise, Veeva ). Support preparation of stability reports for regulatory submissions and annual product reviews (APR/PQR) . Compliance & Inspection Readiness Ensure audit readiness for FDA and international inspections. Support internal/external audits by providing accurate and complete documentation. Ensure stability program compliance with global regulatory bodies (FDA, EMA, MHRA) . Deviation, CAPA & Investigations Document and track stability‑related deviations (e.g., missed pulls, chamber excursions). Assist with investigations and root cause analysis. Support implementation and closure of CAPA actions in collaboration with QA. Cross‑functional Collaboration Partner with: QC Laboratories (testing coordination) QA (compliance oversight) Regulatory Affairs (submission support) Manufacturing (batch tracking) Support new product launches, technology transfers, and lifecycle management . Qualifications & Experience Education Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline Experience 2–5+ years of experience in stability, QC, or GMP documentation in pharmaceutical industry Experience in FDA‑regulated environments required Experience with injectable or sterile products preferred Technical Skills Strong understanding of: ICH stability requirements (Q1A, Q1B) cGMP documentation practices Experience with: Stability tracking systems, LIMS Temperature/humidity monitoring systems Knowledge of data integrity and audit readiness principles Compensation Base Salary: $44,900.00 to $74,950.00 annually. The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job‑related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process. What We Offer Annual performance bonus, commission, and share potential Auto enrollment in a Hikma‑sponsored 401(k) program at a pre‑tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries 3 personal days (prorated based on hire date) 11 company paid holidays Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits Employee discount program Wellbeing rewards program Safety and Quality is a top organizational priority Career advancement and growth opportunities Tuition reimbursement Paid maternity and parental leave Equal Opportunity Employer Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law. #J-18808-Ljbffr Hikma Pharmaceuticals