Quality & Compliance Specialist (Hybrid)
About The Position
When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services. Job Description Summary: Primary responsibility will be to assure the definition, implementation and maintenance of the Site Quality Management System in coordination with the senior management team, PKI engaged Quality Manager’s expectations, Global PKI Quality Management policies, national, and international standards. This position provides the execution of the Quality System and conducting all aspects of that Quality Management System (QMS). Create awareness and provide training and education to all employees on quality processes and programs.
Requirements
- Extensive experience in both internal and external process auditing.
- Proven track record of delivering continual positive process improvement in systems and processes.
- Excellent organizational and communication skills.
- Team management and mentoring skills for internal auditor coordination.
- A good balance of negotiating and influencing skills.
- Be expected to audit customer and TPSP business sites when required.
- Excellent presentational skills.
Nice To Haves
- 1+ years of process auditing experience OR 2+ years of experience working in a regulated laboratory setting
- Associate degree or higher in a scientific discipline.
Responsibilities
- Define, Consolidate and Integrate Quality Management Systems.
- Accept ownership for the Quality Management System between our Customer, PerkinElmer, and Third Party Service Providers (TPSP) by defining it and provide support and leadership necessary to integrate all the key internal and external quality systems, processes and information to ensure consistent Service product quality and drive overall Customer satisfaction.
- Drive consistency to the customer.
- Interface with PE management to ensure customer focus, audit ability, and traceability within the business.
- Improve and establish business processes.
- Create and maintain strong data alignment between internal and external sources of quality data.
- Coordinate Internal Audit Processes.
- Drive customer satisfaction through quality process integration and compliance.
- Develop quality management interface to provide consistency and standardization in reporting.
- Perform internal audits of PE and TPSP on-site processes, assist in development and execution of the internal audit program for the customer.
- Generate audit reports, audit corrective action requests on audit non-conformances and provide support for corrective and preventative action processes.
- Perform activities required to qualify TPSP and integrate them into PKI and Customer quality systems.
- Training & Education and Project management.
- Develop and implement training and education programs, to educate PE employees, TPSP and management on quality processes/standards/results.
- Assist in and facilitate quarterly business relevant review meetings with business leaders.
- Provide advice and support to the Quality Manager and teams on Quality issues/initiatives (e.g. problem solving, identification and escalation of significant Quality issues).
- Other duties as necessary based on business process changes and/or client needs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
