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Quality Assurance Investigator
2 months ago
The Quality Investigator will conduct thorough and timely investigations, develop collaborative relationships with operational leadership and staff across Business Units, and liaise with Quality representatives to facilitate investigations. The role involves using continuous improvement techniques to identify root causes and implementing appropriate Corrective and Preventative Actions (CAPAs). The successful candidate will also be responsible for environmental monitoring, compiling trending data, making recommendations on material disposition based on investigational data, and ensuring compliance with Good Manufacturing Practices (GMP) and FDA regulations.
Key Responsibilities- Conduct detailed investigations to identify root causes and implement corrective actions
- Develop and maintain collaborative relationships with operational leadership and staff
- Liaise with Quality representatives to facilitate investigations and implement CAPAs
- Perform environmental monitoring and compile trending data
- Make recommendations on material disposition based on investigational data
- Ensure compliance with GMP and FDA regulations
- Bachelor's degree in microbiology or a related life science field
- 5+ years of experience in the pharmaceutical industry
- Experience with writing investigations
- Environmental monitoring experience in the pharmaceutical industry
- GMP experience
- Knowledge of Laboratory Information Management Systems (LIMS) or equivalent
- Ability to develop collaborative relationships
- Effective communication skills
- Strong analytical and problem-solving skills
- Ability to work independently and manage multiple tasks
The role involves working in a fast-paced environment with a personal desk space and a laptop. The position requires the candidate to be on-site 5 days a week, Monday through Friday from 8 am to 4:30 pm.