QC Stability Coordinator

The Stability Coordinator will be responsible for overseeing and coordinating stability testing activities for pharmaceutical development, ensuring timely execution of stability pull and testing schedules in collaboration with Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs). This role involves managing schedules, ensuring compliance with procedures, and acting as a liaison between internal teams and external partners. The ideal candidate will have strong organizational skills, experience in pharmaceutical stability programs, and a thorough understanding of regulatory requirements.

Key Responsibilities:

1. Coordination of Stability Testing Schedules:
2. Liaison with CMOs/CTOs:
3. Regulatory Compliance:
4. Deviation Management:
5. Data Management and Documentation:
6. Collaboration and Communication:
7. Continuous Improvement:
8. Training and Support:

All other relevant duties as assigned

Job Requirements

•

• Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree or certification in Quality Control or Stability Testing is preferred.
• Experience:
• Skills:
• 3+ years of experience in pharmaceutical stability programs or quality control within the pharmaceutical or biotech industry.
• Proven experience coordinating with CMOs/CTOs for stability testing or related activities.
• Strong understanding of regulatory requirements for stability testing (e.g., FDA, EMA, ICH guidelines).
• Exceptional organizational and time-management skills with the ability to manage multiple schedules and priorities.
• Strong communication and interpersonal skills, with the ability to build effective relationships with internal and external stakeholders.
• Detail-oriented with a commitment to accuracy and regulatory compliance.
• Effective problem-solving skills, particularly in managing deviations and implementing CAPA.

Preferred Qualifications:

• Experience with electronic data management systems (e.g., LIMS).
• Knowledge of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
• Familiarity with stability study design and data analysis.

Working Conditions:

• Office-based position with occasional travel to CMOs/CTOs, manufacturing sites, or external partners as required.
• Ability to work effectively across different time zones as needed.