Description
Main Responsibilities- Conduct and write formal investigations for plant quality issues.
- Perform impact assessments and investigate to the depth commensurate with the identified risk.
- Analyze and organize data from multiple sources.
- Write technical reports that include executive summaries.
- Review and evaluate sensitive, confidential information and develop recommendations for use by plant Quality management.
- Utilize data analysis compute tools and statistical analysis tools to provide objective data evidence to support conclusions.
- Manage cross-functional teams to determine root cause, implement appropriate CAPA and close investigations.
- Lead management of document change requests for method SOPs and material specifications.
Education / Experience Requirements
- BS degree with 5+ years relevant Quality / QA experience.
- Must have experience working in a cGMP Biotech and/or Pharmaceutical environment.
- Experience with leading quality system investigations is required.
- Previous experience in other Quality Assurance functions is a plus.
- Experience with LIMS (Laboratory Information Management System) and electronic systems (Trackwise, etc) is preferred. Ability to work independently and as a team player.
- Flexible and adaptable to change.
- Detail oriented and ability to multi-task
- Strong organizational and verbal / written skills.
MUST HAVE MEDICAL DEVICE EXPERIENCE.
To find out more about Real please visit www.realstaffing.com