Investigators will perform the following activities:- Investigate, write and close out root cause investigations/CAPAs.
- Implement necessary follow-up verification checks on investigation Corrective and Preventive Action (CAPA} items
- Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations
- Review Company's SOPs related to the quality investigational system and assist with improvement/revisions
- Attend any investigational related meetings.
Knowledge of the following areas are critical: - Manufacturing Packaging and Inspection – Investigations experience
- GMP Pharma experience
- Experience performing investigations in a Pharma environment
- Experience writing CAPAs in a Pharma environment
- Some knowledge of aseptic processing
- Demonstrated problem solving skills
Helpful experience: - Quality Investigations and a FDA remediation/Combination Products pharmaceutical manufacturing environment
- Ability to demonstrate analytical thinking skills
- Root Cause Analysis performed in an aseptic environment
- Investigations performed in an aseptic environment
- cGMP's both US and other countries
- Manufacturing Environment, Processes and Intradepartmental Linkages
- Additional biology or microbiology experience
- FDA Compliance and GMP experience