Vacancy expired!
- Support the creation, execution, extension, and/or closure of site Deviations (Events), CAPAs and Change Management
- Administration and data entry into site Learning Management System
- Output cross-functional deliverables through meeting minutes
- Administration of Client Communication activities, as needed, in relation to Deviations (Events) & Change Management
- Support Measurement/Monitoring of Quality System data for submission of monthly metrics to Quality Management
- Support Client Audits and Regulatory Inspections as needed
- Bachelor's degree in a scientific discipline or related field.
- Minimum 4 years of experience working within Quality in support of cGMP manufacturing or similarly regulated environment.
- Change Control/Change Management Program experience
- CAPA Program Management experience
- Knowledge of Training requirements of cGMP manufacturing or similarly regulated environment
- Understanding of Good Documentation Practices and Document/Records Controls
- Ability to coordinate Quality System records and drive to completion
- Experience supporting client audits and regulatory inspections
- Organized and detailed oriented with strong and effective written and verbal skills
- Strong interpersonal communication skills
- Ability to work independently within prescribed guidelines, as well as collaboratively as part as part of a team
- Proven ability to obtain direction and commitment to ensure that objectives are completed by due dates.
- Knowledge of governmental regulatory guidelines, directives, and regulations relating to the manufacture of biologics and pharmaceuticals.
- Change Control/Change Management Program experience.
- CAPA Program Management experience.
- CMO experience.
- Ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
Vacancy expired!