Validation Specialist

Who We Are
 

Founded in 2013, Organigram is a leading Canadian licensed producer, focused on producing high-quality, indoor-grown cannabis for adult recreational consumers in all provinces and the Yukon. Headquartered in Toronto (Ontario), Organigram has three state-of-the-art cultivation and processing facilities in Moncton (New Brunswick), Winnipeg (Manitoba) and Lac-Supérieur (Quebec), and our adult-use products can be found in retail outlets from coast-to-coast. Organigram's adult-use brands include Edison, SHRED, monjour, Laurentian Cannabis, Holy Mountain, Big Bag O’Buds, Tremblant Cannabis and Trailblazer.
 

Our mission is to delight consumers with trusted brands that deliver innovative cannabis products and experiences while promoting education and industry advocacy.
 

Over the past year we have seen significant growth in this emerging cannabis industry and attribute this growth to our team members. We believe our deep-rooted culture; our values and our welcoming work environment have contributed to our overall success. Our focus on innovation, responsiveness to the needs of our customers and our people–centric approach have helped us become a trusted name amongst our stakeholders - be it our customers, partners, investors, our team members, and the communities that we support.
 

Why work with us?
 

Organigram is a diverse and inclusive organization that cares about you and the community you live in. Our competitive salary and benefits, education reimbursement and flexible work environment are designed to work for you as you grow and develop in your career. We offer an annual wellness credit and unlimited vacation to support your health and wellbeing. And you can feel good knowing our Organigram Operating for Good program provides you with the opportunity to support your community through sponsored volunteer initiatives.

Location: Moncton

Status:  Full-time, Contract

Reports to: Senior Manager, QA

The QA Validation Specialist is a self-starter who takes initiative, displays problem-solving and decision-making abilities, has excellent organizational skills and can maintain a positive, professional attitude in a fast-paced and changing work environment. The successful candidate will possess strong interpersonal skills and sense of urgency coupled with a proven ability to supervise staff.

Responsibilities:

• Carry out responsibilities in accordance with our best practices, policies, procedures, applicable acts and regulations;
• Leads the development and maintenance of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Qualification, Test Protocols (IQ/OQ/PQ), and Summary Reports;
• Development of validation plans and process validation program including assessments of Critical Quality Attributes and Critical Process Parameters;
• Maintains and enhances validation programs for existing equipment, facility/utility commissioning and qualification, and computer systems;
• Support the Execution of Test Protocols, including identification and resolution of non-conformances/deviations;
• Ensure that relevant and compliant documentation is generated, executed, and summarized as required, by site SOP, company policy, and international cGMP regulations;
• Ensure all areas of quality management system are up to date and there are no backlogs in the system i.e. on time completion of Change controls, Internal audits, Trainings, Deviations, CAPAs and SOPs etc;
• Support the ongoing development and maintenance of the Quality Management System;
• Monitor data trends; identify and facilitate changes to achieve specifications and targets;
• Act as quality contact for quality projects and continuous improvement efforts regarding Validation and Quality Risk Management;
• Tracking and managing change control activities for multiple concurrent projects;
• Contribute to the generation and review of required documentation (such as SOP’s, protocols) to support the validation lifecycle requirements;
• This role will also be required to analyze and summarize periodic reviews of previously validated systems and to develop and implement protocols/changes based on the outcomes of those reviews;
• Any other job assigned.

Qualifications:

• Minimum Bsc. or equivalent experience;
• Experience in similar manufacturing environment;
• Previous experience in a QA management or supervision;
• Proficient in Word, PowerPoint, Outlook, Excel, inventory management systems (ERP);
• Strong problem solving, decision making and leadership skills;
• Strong communication (written and verbal) skills;
• Ability to work individually as well as in a team environment;