Job Description
This position is in the Quality Assurance organization in Florence, KY reporting to the Site Director and indirectly to the Americas Regional EM Quality Manager. The position is accountable for ensuring product/process integrity for compounding using performance monitoring and improvement programs. It involves taking ownership and maintaining the overall quality performance of the site regarding nonconformances. It requires performing periodic process audits / gap assessments to address gaps and nonconformances and conducting continuous improvement initiatives (QIT) within the plant. It involves leading and addressing customer issues daily with emphasis on on-going monitoring and performance improvements, leading the containment activities and addressing all customer issues in a timely fashion with root cause, corrective, and preventive action.
- Improving quality performance of the site.
- Perform weekly reviews with manufacturing/on-site warehouse on all their non-conformances and work with them on Root cause, Corrective action, Preventive Action through the Quality Improvement Team (QIT) program.
- Performing periodic process audits / gap assessments to address gaps, nonconformances and escapees.
- Ensuring quality notifications (QNs) are completed in a timely fashion. Ensuring all Customer QNs have a robust corrective action plan completed quickly (CAPA / 8D).
- Reducing non conformances from the plant and working with manufacturing and T&I/Engineering/CTG to eliminate repeat QNs and issues from production.
- Getting root cause investigation and corrective/preventive actions in place and ensuring CAPA/8D is completed on all NC’s.
- Ensuring containment activities are performed when a nonconformance is discovered to prevent repeat escapees.
- Coming up with continuous improvement ideas to help improve and increase efficiency / productivity / reduce waste in our internal processes
- Support internal qualification requirements for customers
- Supporting any customer audits, cost reduction activities, performing lessons learnt and best practice sharing within teams
- Periodic reporting of quality issues, performance and metrics to management and team members
- Leading registrar certification audits
- Participates in formulating quality standards, policies, programs, plans, procedures, and practices.
- Perform semi-complex statistical analysis as related to quality. Supports in the analysis of production limitations and problems for continuous improvement opportunities.
- Participates in the implementation of Quality Mgmt. Systems and Techniques, (QMST).
- Conducts internal audits and/or surveys/assessment to determine acceptability of quality controls. Participate and lead internal audits.
- Write internal procedures or processes as needed