Quality Systems Developer

Quality Systems Developer

Department : Quality Assurance

Reports to : Senior Quality Systems Manager

FLSA Status : Exempt

Location : Tallahassee, Tampa or Jacksonville FL preferred, Hybrid-75% remote, onsite 25%, typically at least 2 days / week on site

Travel : Travel to FL production sites as needed

ROLE SUMMARY

The Quality Systems Developer position works to create and maintain Quality Systems in support of enterprise, Brand Partner, and Quality operations.

The Quality Systems Developer reports to the Senior Quality Systems Manager, and will oversee, and directly assist with, the support of internal / external examinations including systems design and coordination of Quality procedures, due diligence completion, and support the department analytically and logistically, as necessary, within the scope of Quality Systems development, deployment, and maintenance.

The Quality Systems Developer role, who works with the Senior Quality Systems Manager, and site Quality / Operations leadership, will be responsible for all Quality Systems, Quality Systems programs, and enterprise documents associated with Quality Systems and their subsequent maintenance.

This position is expected to work independently with minimal supervision by applying sound decision-making processes, organizing, and prioritizing, and delegating routine duties and special assignments to complete tasks in an efficient manner as it pertains to Quality Systems.

In tandem with site QA Management, Regional QA Management, and National Director of Quality, the Quality Systems Developer will be engaged in the development of Quality processes and procedures to develop / monitor Quality metrics and will maintain applicable records and perform audits, as necessary, associated with Quality Systems.

KEY DUTIES AND RESPONSIBILITIES

• Assist with change management (document, material, equipment, process) activities including tracking updates for enterprise and Brand Partner policies, procedures, forms, guidelines, and educational presentations and activities.
• Develop, maintain, and support set-up of integrated Quality Systems at new sites within the Trulieve enterprise and associated Brand Partners
• Tracking and reporting of Quality Systems audit events, recommendations, and issues including coordination of management responses and tracking resolution or remediation.
• Assist in developing, implementing, and monitoring annual Quality initiatives and data which are presented during annual Management Review Meetings.
• Perform Quality risk assessments, incident investigations, write summary reports associated with Quality Systems utilized.

Understand computer system validation and Quality Management Systems and their associated impact on operations they are deployed in.

• Experience with Quality protocols is essential to develop new approaches, assessments, and suggest solutions associated with Quality Systems development and / or Systems already deployed.
• Able to create various types of gap assessments and process maps (business data) for Quality assessments.
• Assess operating procedures to ensure compliance with Quality Controls and verification requirements associated with Quality Systems.
• Assess proposed changes, deviations to program and project documentation to assure compliance with Quality requirements associated with Quality Systems.
• Track and / or monitor the implementation and validation of Quality Controls in accordance with approved Quality standards associated with Quality Systems.
• Develop and present status reports and / or Key Process Indicators (KPIs) to management.
• Performs analytics and gathers sufficient background information including relevant authorities (laws, statutes, procedures, etc.

and other information necessary to appropriately plan and conduct projects associated with Quality Systems and their intended deployment.

• Prepares correspondence and responses to external support and audit activities as needed.
• Facilitates communication between department management or staff and external compliance support associated with Quality Systems.
• Prepares and assess Quality programs for in-house design, development, and operational projects to assure proper Quality Systems overlay.
• Assess and contribute to the development of project plans to ensure that Quality and their associated Systems are properly considered.
• Maintain effective relationships with external parties, such as vendors, suppliers, wholesalers, and customers associated with Supplier Quality.
• Teams with IT and InfoSec counterparts to ensure Quality Systems created and implemented do not pose a risk / threat to Trulieve or Brand Partner data integrity.
• Write, update, and maintain Quality SOP's (Standard Operating Procedures) associated with use of new Quality Systems and / or Systems already deployed.
• Track data associated with customer complaints regarding Quality within QMS and report negative trends.
• Respond to Quality System Support Tickets in a timely, professional, and thorough manner ensuring all needs are met by users of the Quality Management System.
• Ensures management is informed of conditions and proposes corrective actions associated with normal duties and strategic projects.
• Expeditiously performs project tasks and related assignments with appropriate attention to detail and due professional care.
• Other duties as assigned.

SUPERVISORY RESPONSIBILITY

• This position will be responsible for compliance with all standards that accompany this description and is responsible for the accuracy, integrity, security, and program information under the direct control of this position as applicable with Quality Systems.
• This position may include direct supervisory responsibilities

SKILLS AND QUALIFICATIONS

• High School Diploma (2- or 4-year Degree or Equivalent Experience)
• Flexibility to work non-traditional business hours as needed. Trulieve operates within multiple time zones and in different shifts and the ideal candidate will have the occasional need to be in the facility during non-traditional business hours including operating between applicable time zones for continuity among state operations.
• Medical / recreational marijuana, pharmaceutical, or food manufacturing experience is preferred.
• Strong communication skills and a desire to collaborate with others to achieve success.
• Experience working with many file types and high attention to detail required
• Ability to work effectively under pressure in a fast-paced, time-sensitive environment with shifting priorities, multiple deadlines, and a diverse workforce.
• Knowledge of ISO 9001 standards is preferred.
• Experience working with current Good Manufacturing Processes (cGMP) and Good Documentation Practices (GDP) is preferred.
• Work environment includes normal office to facility operations with cold / hot conditions.
• Comply with all company policies and procedures.
• Required to use all personal protective equipment (PPE) provided by the company in compliance with regulations.
• Quality, safety-minded, reliable, precise, and self-motivated.
• Strong interpersonal, communication and analytical skills.
• Self-Starter, organized, problem-solving and detail oriented.

ADDITIONAL MINIMUM QUALIFICATIONS

Must be able to move intermittently throughout the workday. Due to the nature of our business, it is advocated that when representing Trulieve that our professionalism meets the needs of the medical / recreational patient / customer base that we respectively serve.

To uniformly align with the organization, an individual must be able to provide a level of communication that aligns respectively with the diversification of our patients / customers which may exhibit opportunities to assess the situation and apply meaningful service.

In addition, must be able to quickly identify and insert additional support where needed to deescalate situations without compromising Trulieve’s or Brand Partners objective in serving our patient / customer base with excellent customer service.

Either with or without reasonable accommodation, must be able to sit, stand, stoop, kneel, use hands and finger to operate equipment including computers.

Must be able to work in office and field environments in all types of weather. Must be able to work seated or standing, as appropriate, at desk and counter height position for extended periods of time.

Must be able to lift and move 25 lbs. Must be able to talk and hear conversational levels. Specific vision abilities required by this job include close vision, peripheral vision, and ability to adjust focus.

Must be able to pass a level 2 background screening.

WORK SCHEDULE

45+ hours weekly with flexible hours depending on business needs. Must be available to work occasional evenings, weekends, and holidays.

This position will be hybrid work from home (75%) and on-site (25%).

Equal Opportunity Employer Trulieve Supports a Drug Free Workplace