Quality Systems Specialist

QUALITY SYSTEMS SPECIALIST

- This position will support the execution of the Site's Quality Management System Processes and deliver Quality System projects.
- This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements.
- This role will involve liaising with the Franchise/Sector teams on driving improvement and streamlining of the assigned processes.

MAIN DUTIES AND RESPONSIBILITIES

- Drives compliant execution of the following for their assigned processes and projects

Manages specified quality system processes - Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements
- Work directly with the various 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 all metric review meetings.
- Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards
- Understand and uses data, key metrics and statistical methods, quality tools or computer based solutions to improve processes
- Responsible for identifying and communicating the need for process improvement opportunities to responsible management
- Identifies personnel that require training on the relevant processes and rolls out training as required
- Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes. Lead and drive improvements as required
- Establishes linkages to other key quality systems/programs like Design Controls, Technology Transfer, Production & Process Controls, External Manufacturing, Calibration, Preventive Maintenance, etc
- Support the assigned processes during internal and external audits
- Conducts internal audits to ensure compliance to regulatory and customer requirements
- Responds to and drive/participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions
- Represents the processes as required at cross-site meetings
- Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff

EDUCATION AND EXPERIENCE

- At a minimum a Diploma in a Quality, Science or Engineering discipline 3 or more years of related experience
- Desirable a Degree in a Quality, Science or Engineering discipline with 5 or more years of related experience
- Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems
- Ability to prioritize and manage the workload and as required, be able to manage shifting priorities based on critical deadlines so that business needs are always met
- Demonstrate excellent communication skills (verbal and written) with all levels within the organization, clients and regulatory auditors
- Must show innovative development techniques and strategic thinking abilities
- Demonstrated success in managing multiple projects
- Ability to develop and give presentations on technical and regulatory topics
- Ability to work on own initiative and a high level of attention to detail
- Ability to train/mentor associates
- Ability to effectively deal with a variety of conflicting issues and diplomatically solve those issues
- Ability to read, analyze, and interpret complex technical documents and manuals
- Ability to define problems, collects data, establish facts, and draw valid conclusions