Driven by a commitment to research, quality and service, PDI, Inc. provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The purpose of the Quality Systems Specialist is to perpetuate Enterprise-wide Quality and Regulatory compliance and continuous improvement through assisting with the implementation and maintenance of robust quality systems and processes and engaging with related projects. This includes but is not limited to: Change Control Management, Enterprise GXP Training and Qualification, Technical Administration of the Electronic Quality Management System (housing Document Control, Training, Change Control, CAPA, Non-conformances, and Complaints), and Validation of Systems related to the Electronic Document Management System employed by the Company.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

The essential function of the Quality Systems Specialist is to support business and compliance objectives by assisting with the development and maintenance of a robust, GMP-focused, compliant, and continually improving Quality Systems program across the North America sites for all applicable Regulatory categories. It includes responsibility and accountability for electronic and structural system administration, training course content, assessment/qualification methods, conduct and compliance with GXP, ISO, EPA, OSHA, and other applicable regulations and guidelines.

GXP TRAINING AND QUALIFICATIONS: 

• Assist with the development and implementation of Quality Systems and processes, including the development and delivery of content, in accordance with Corporate Quality Objectives and in collaboration with team.
• Work collaboratively with internal customers including Corporate, and Sites to establish and achieve qualification objectives.
• Maintain applicable SOPs and processes.

PROCESS AND DOCUMENT CHANGE MANAGEMENT: 

• Review process and document change requests and documentation for compliance.
• Process all change requests (process and documents) for review, approval, and issuance.
• Distribute copies of controlled documentation as requested.
• Ensure revision control of all controlled documents.

SYSTEM MANAGEMENT: 

• Technical Administration of the Electronic Quality Management System
• Review, prepare, execute, approve, assist with, and maintain applicable Change Management and Validation documentation for retrospective, concurrent, and prospective validation compliance specific to the Electronic Quality Management System.
• Assist with current and future electronic processes and workflows in the QMS.

CUSTOMER SERVICE: 

• Assist internal customers with technical support and status inquiries
• Provide copies of documentation for internal and external distribution
• Participate and support business optimization, new product and compliance projects

REPORTING & ANALYSIS: 

• Create monthly trending reports and metrics for Quality Review Committee (QRC), and as requested by internal stakeholders as appropriate
• Deliver departmental metrics as requested
• Analyze and plan upgrade strategies to ensure compliance

AUDITS, INSPECTIONS, AND COMMITMENTS:

• Participate in the organization and execution of audits and inspections, including personnel, requests, documentation, and process flow
• Ensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments
• Maintain documentation and records in accordance with regulations and internal policies
• Act as SME for system inquiries during audits and regulatory inspections if requested

PERFORMANCE MEASUREMENTS:

• Robustness of Programs
• Regulatory and GMP Compliance
• On-time Completion
• Effective Metrics and Reporting
• Values - Centered Execution

QUALIFICATIONS:

EDUCATION/CERTIFICATION

Bachelor of Science or Bachelor of Arts degree or equivalent years relevant experience

REQUIRED KNOWLEDGE

Strong proficiency in MasterControl or another electronic Quality Management System, standard computer systems and applications including Microsoft office Suite, Internet Browsers, and Adobe PDF Applications

SKILLS/ABILITIES

Breadth of knowledge to expertly navigate and convey the requirements for the GMP Quality System in accordance with FDA regulations and ISO Standards. Strong positive influencing and collaboration skills are required. Must be able to train, coach and motivate Associates to affect a culture of Quality and compliance. Able to operate under a fact pace environment. Must be agile and able to quickly flex to changing business priorities. Strong written and verbal communication skills with all organizational levels and external partners. Ability to coordinate cross-functional teams and facilitate troubleshooting of complex problems. Ability to meet needs of Enterprise by effective prioritization and task balancing.

WORKING CONDITIONS:

No hazardous or significantly unpleasant conditions. Standard office environment. Must be able to sit in front of a computer for extended periods of time