Full-Time

Quality & Compliance Specialist

Posted on 11/18/2024

PerkinElmer

PerkinElmer

Compensation Overview

$71.2k - $100kAnnually

Junior, Mid

Massachusetts, USA

Job requires presence at customer site in Massachusetts.

Category
Healthcare Administration & Support
Medical, Clinical & Veterinary
Requirements
  • Bachelor’s degree in a relevant field with 2+ years of experience in both internal and external auditing. OR an Associate’s degree with 4+ years of experience
  • Experience in conducting root cause analysis.
  • Experience in investigating process deviations.
  • Proven track record of delivering continual positive process improvement in systems and process.
  • Excellent organizational and communication skills.
  • A good balance of negotiating and influencing skills.
  • Be expected to travel to customer and business sites when required.
  • Excellent presentation skills for delivery of training.
Responsibilities
  • Define, Consolidate and Integrate Quality Management Systems.
  • Be part of the team that accepts ownership for the Quality Management System between our Customer, PerkinElmer, and Third Party Service Providers (TPSP) by defining it and providing support and leadership necessary to integrate all of the key internal and external quality systems, processes and information to ensure consistent Service product quality and drive overall Customer satisfaction.
  • Drive consistency for the Customer: PKI Quality Management Interface ensures customer focus, audit ability, and traceability within the business.
  • To work collaboratively with the customer Compliance Teams to promote continuous improvement.
  • To improve and establish business processes that lead to a comprehensive Quality Management System Interface.
  • Create and maintain strong data alignment between internal and external sources of quality data.
  • Consult leadership on quality-based risk management for the service.
  • Execute Internal Audit Processes.
  • Drive customer satisfaction through quality process integration and compliance.
  • Perform internal audits of PKI and TPSP on-site processes, assist in development and execution of the internal audit program for the Customer: PKI interface addressed by customer expectations, regulations.
  • Generate audit reports, audit corrective action requests on audit non-conformances and provide support for closed loop corrective and preventative action processes. Conduct root cause analysis.
  • Perform activities required to quality approve TPSP and integrate them into PKI and Customer quality systems.
  • Training, Education and Project management.
  • Develop and implement training and education programs, to educate PKI employees, TPSP and management on quality processes, standards and results.
  • Provide support to the Quality Manager and teams on Quality issues/initiatives (e.g. problem solving, identification and escalation of significant Quality issues).

Company Stage

N/A

Total Funding

N/A

Headquarters

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Founded

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