Quality & Compliance Specialist; Hybrid

Quality & Compliance Specialist (Hybrid)

King of Prussia, Pennsylvania

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.

• Define, Consolidate and Integrate Quality Management Systems. Accept ownership for the Quality Management System between our Customer, Perkin Elmer, 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.

Critical

Skills:

• Extensive experience in both internal and external process auditing.
• Proven track record of delivering continual positive process improvement in systems and processes.

Basic Qualifications:

• 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.

Preferred Qualifications:

• 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.

Working Environment:

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses, etc.) in laboratory.
• Job pace may be fast and job completion demands may be high.
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite.
• Occasionally operate a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Potential risk to lab-based hazards including but not limited to extreme temperature, biological materials, and hazardous chemicals.

The annual compensation range for this full-time position is $80,000 to $88,000. The final base pay offered to the successful candidate will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.

Perkin Elmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. Perkin Elmer is committed to a culturally diverse workforce.

We are an equal opportunity employer. Learn more about equal employment opportunity protections in the EEO resources linked on our site.