Job Purpose:
The sucessful candidate will provide oversight to Compliance Specialists and Technical Writers. Assure the execution and conduct all aspects of the Quality Management Systems (QMS) used by PerkinElmer and the Client. Create awareness and provide training to all employees on quality processes and programs.
Key Responsibilities:
Ownership for the Quality Management System between our Customer, PerkinElmer, and Third Party Service Providers (TPSP).
Ensure consistent service product quality and drive overall Customer satisfaction.
Perform internal audits of PerkinElmer and TPSP on-site processes.
Assist in development and execution of the internal audit program for the Customer.
Generate audit reports, audit corrective actions on audit non-conformance and provide support for corrective and preventative action processes.
Perform activities required to quality TPSP and integrate them into PerkinElmer and Customer quality systems.
Develop and implement training and education programs, to educate PerkinElmer employees and TPSP and management on quality processes, standards and results.
Provide advice and support to the Quality Manager and teams on Quality issues/initiatives.
Provide data for CPI/KPI tracking.
Experience and Competencies:
Bachelor’s degree or an appropriate combination of education and experience
Team management and mentoring skills
Proficiency at internal and external auditing
Familiarity with the QMS and how to execute the component activities of the QMS
Familiarity with Good Documentation Practices
Familiarity with regulations governing GMP/GLP/GCP activities
Familiarity with the CMMS and how activities are recorded in the CMMS
Join our Team!
We are strongly committed to the development of your career and giving you opportunities to learn and grow.
We make a difference for you while you make a difference in the world!