Stability Programs Coordinator

RXinsider LTD.; Bedford (OH); On-site; USD 44,900 - 74,950; Full time

Benefits offered by this job

Annual bonus

401(k) plan

PTO 20 days

Personal days

11 company paid holidays

Health insurance

Dental insurance

Vision insurance

Disability insurance

Life insurance

Prescription drug coverage

Wellbeing rewards program

Tuition reimbursement

Parental leave

Job summary

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

You will manage sample lifecycles, ensure data integrity, and prepare stability reports for regulatory submissions in a regulated manufacturing environment. The role requires 2–5+ years in stability/QC/GMP within FDA-regulated settings, with a Bachelor's degree in a related field and knowledge of ICH guidelines.

Qualifications

• Bachelor's degree in Chemistry, Pharmaceutical Sciences, Life Sciences, or related discipline
• 2-5+ years of stability, QC, or GMP documentation experience in pharmaceutical industry
• Experience in FDA-regulated environments required
• Experience with injectable or sterile products preferred

Responsibilities

• Coordinate and manage stability programs in line with ICH Q1A(R2) and company procedures
• Oversee sample receiving, labeling, storage, and tracking of stability samples
• Maintain stability protocols, reports, and logs per cGMP and ICH guidelines
• Ensure audit readiness for FDA and international inspections; support internal/external audits
• Document deviations, CAPA investigations, and ensure closure with QA
• Collaborate cross-functionally with QC, QA, Regulatory Affairs, and Manufacturing

Skills

ICH stability

cGMP documentation

Stability tracking

LIMS

Temperature monitoring

Data integrity

Audit readiness

Education

Bachelor's degree in Chemistry/Pharmaceutical Sciences

Tools

LIMS

TrackWise

Veeva

Job description

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

You will manage sample lifecycles, ensure data integrity, and prepare stability reports for regulatory submissions in a regulated manufacturing environment. The role requires 2–5+ years in stability/QC/GMP within FDA-regulated settings, with a Bachelor's degree in a related field and knowledge of ICH guidelines.