Qc Stability Coordinator

**Key Responsibilities**:

- ** Coordination of Stability Testing Schedules**:

- Develop and manage stability pull and testing schedules in collaboration with CMOs/CTOs to ensure timely execution of stability studies.
- Monitor adherence to schedules, proactively addressing any delays or issues to maintain compliance with project timelines.
- Ensure all stability testing activities are performed in accordance with approved protocols, procedures, and regulatory requirements.
- ** Liaison with CMOs/CTOs**:

- Act as the primary point of contact for CMOs/CTOs regarding stability testing activities, fostering strong communication and collaboration.
- Coordinate the transfer of stability samples, protocols, and related documentation between internal teams and external partners.
- Review CMO/CTO stability testing plans to ensure alignment with company standards and regulatory expectations.
- ** Regulatory Compliance**:

- Ensure all stability testing activities comply with applicable regulatory requirements, including FDA, EMA, ICH, and other global standards.
- Maintain up-to-date knowledge of regulatory guidelines related to stability testing and ensure their integration into testing schedules and procedures.
- Support regulatory submissions by providing stability-related documentation and data as required.
- ** Deviation Management**:

- Investigate and resolve deviations related to stability testing at CMOs/CTOs, conducting root cause analyses and implementing corrective and preventive actions (CAPA).
- Monitor the effectiveness of CAPA implemented by CMOs/CTOs to ensure continuous compliance and quality improvement.
- Document and report deviations and resolutions to internal stakeholders and management.
- ** Data Management and Documentation**:

- Oversee the collection, review, and documentation of stability data generated by CMOs/CTOs, ensuring accuracy, completeness, and compliance.
- Maintain robust data management practices, including proper storage, retrieval, and archiving of stability-related documentation.
- Support the implementation and maintenance of electronic systems (e.g., LIMS) for stability data management.
- ** Collaboration and Communication**:

- Work closely with cross-functional teams, including Quality Control, Quality Assurance, Regulatory Affairs, and Manufacturing, to align stability testing with project goals.
- Communicate effectively with internal and external stakeholders, providing clear updates on stability testing progress and issues.
- Represent the stability function in meetings and discussions related to pharmaceutical development.
- ** Continuous Improvement**:

- Identify opportunities to streamline stability testing processes and improve coordination with CMOs/CTOs.
- Participate in internal audits and contribute to the development and refinement of standard operating procedures (SOPs) for stability activities.
- Support quality improvement initiatives related to stability testing and data management.
- ** Training and Support**:

- Provide training and guidance to internal teams and external partners on stability testing procedures and regulatory requirements.
- Support the professional development of team members involved in stability activities, fostering a culture of compliance and excellence.

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**:

- 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).
- ** Skills**:

- 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.