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:
PROCESS AND DOCUMENT CHANGE MANAGEMENT:
SYSTEM MANAGEMENT:
CUSTOMER SERVICE:
REPORTING & ANALYSIS:
AUDITS, INSPECTIONS, AND COMMITMENTS:
PERFORMANCE MEASUREMENTS:
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
BENEFITS
PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:
PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.
At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.
#LI-PDI
#LI-ONSITE