Job Title: Quality Systems Specialist
This is a contract position that will support the execution of the Site Quality Management System Processes and deliver Quality System projects.
The successful candidate will drive the flawless and compliant execution of assigned processes to meet customer and business needs while ensuring compliance with regulatory requirements.
Main Duties and Responsibilities:
* Drives compliant execution of assigned processes and projects.
* Works directly with owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner.
* Compiles, contextualizes, evaluates, and presents Quality Systems data and metrics for metric review meetings.
* Understands and uses data, key metrics, and statistical methods, quality tools, or computer-based solutions to improve processes.
* Responsible for identifying and communicating process improvement opportunities to management.
* Identifies personnel requiring training on relevant processes and rolls out training as required.
* Examines/reviews systems and processes to identify areas for review, improvement, change, or elimination.
* Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, etc.
* Supports assigned processes during internal and external audits.
* Conducts internal audits to ensure compliance to regulatory and customer requirements.
* Responds to and drives/participates in investigations and corrective action implementation for identified quality issues.
* Represents the processes at cross-site meetings.
* Assists in creating a culture of quality awareness and communicates the quality management system to all staff.
Education and Experience:
* At least a Diploma in a Quality, Science, or Engineering discipline with 3+ years of related experience.
* Desirable: Degree in a Quality, Science, or Engineering discipline with 5+ years of related experience.
* Proficiency in applicable GMP/QSR regulations and in-depth knowledge of Quality Systems.
* Ability to prioritize and manage workload, as well as manage shifting priorities based on critical deadlines.
* Excellent communication skills (verbal and written) with all levels within the organization, clients, and regulatory auditors.
* Ability to work on own initiative and maintain a high level of attention to detail.