Stability Administrator

About the role

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Stability Administrator to join our team.

Key Responsibilities

• Manage stability programs in accordance with ICH Q1A(R2) and Hikma procedures.
• Maintain stability schedules for commercial products, validation batches, and stability commitments.
• Clock in sample pulls and testing timelines (e.g., 0, 3, 6, 12, 24, 36 months).
• Ensure alignment with regulatory commitments (ANDA/NDA submissions).
• 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.
• Maintain stability protocols, reports, and logs in compliance with cGMP (21 CFR Part 210/211), ICH guidelines, and 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).
• 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).
• 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, and experience with stability tracking systems, LIMS, temperature/humidity monitoring systems, and 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

Recruiters

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions. In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

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.