Katalyst Healthcares and Life Sciences
Responsibilities:
- Responsible for Supplier Quality Management program and Supplier Audits.
- Responsible for communicating and working with Suppliers in regard to Quality issues.
- Participate on Supplier Improvement project teams.
- Responsible for Incoming Inspection for raw materials in the plant.
- Assist in internal, ISO/FDA, customer, and regulatory audits.
- Responsible for SAP updates for the Quality Module (QM Views, inspection plans, Quality info records).
- Responsible for performing Validations associated with Supplier related changes.
- Performing associate ISO/GMP training.
- Responsible for tracking Supplier quality on a monthly / quarterly basis, i.e. RFT, Notifications.
- Presenting to management quality and regulatory issues on a timely basis.
- Responsible for revising and creating Buy Specifications and working in QDMS.
- Work closely with Purchasing on Supplier related activity.
- Other duties as required to support the needs of the business.
- Bachelor's degree required.
- Audit training preferred.
- Previous Lead Auditor experience preferred.
- Five years' audit experience preferred.
- Computer Skills / Microsoft Office - Proficient.
- ISO 9001:2008, ISO 13485:2003 and 21 CFR Part 820 knowledge - Proficient.
- Problem solving skills with ability to get to root cause - Proficient.
- Validation process knowledge - Basic.
- Organizational skills - Proficient.
- Project management - Proficient.
- Communication and presentation skills - Proficient.
- Ability to communicate effectively with all layers of the facility - Proficient/
- Six Sigma/Lean knowledge preferred.
- Statistics background preferred.