Stability Program Lead

RXinsider LTD.; Bedford, Northern (OH, KY); Hybrid; USD 70,000 - 95,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

20 days PTO

11 holidays

Health, dental, vision benefits

Job summary

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio is seeking a Stability Administrator to coordinate stability programs for oral and sterile products.

You will maintain schedules, manage samples, and ensure data integrity in cGMP-compliant systems, while supporting regulatory submissions and audits. The role requires 2–5+ years in stability/QC in FDA-regulated environments, with preference for injectable or sterile product experience.

Qualifications

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline.
• 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.

Responsibilities

• Coordinate 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).
• Oversee receiving, labeling, storage, and tracking of stability samples.
• Manage stability chambers and monitor temperature/humidity; elevate excursions.
• Maintain documentation and data integrity in cGMP systems.
• Support audits and inspection readiness by providing complete documentation.
• Collaborate with QC, QA, Regulatory Affairs, and Manufacturing for lifecycle management.

Skills

Stability program coordination

Data integrity

Audit readiness

Regulatory compliance

Education

Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline

Tools

LIMS

TrackWise

Veeva

Job description

Hikma Pharmaceuticals USA Inc. in Bedford, Ohio is seeking a Stability Administrator to coordinate stability programs for oral and sterile products.

You will maintain schedules, manage samples, and ensure data integrity in cGMP-compliant systems, while supporting regulatory submissions and audits. The role requires 2–5+ years in stability/QC in FDA-regulated environments, with preference for injectable or sterile product experience.