Job Description

Overview:
Reporting to Manager, Quality Systems, the Quality Systems Associate will provide exceptional support as an important contributor to the quality systems group. As a critical quality function, this role will be primarily responsible to drive and maintain the day to day operations of the quality system. In this role, the Quality Systems Associate will monitor quality events, conduct investigations, and solve complex issues using critical thinking and established investigational techniques.Scope of Role: Participate in investigation of complaints, incidents, deviations and CAPA. Evaluate impact of proposed changes and identify appropriate risk assessments and action plans as part of the change control program. Assist with administration and maintenance of the company's electronic quality management systems and internal programs, including timely closure of investigation and quality events. Report on and evaluate metrics, identify trends and initiate action to address trends Support internal regulatory compliance by working with interdepartmental teams to establish and/or improve processes by reviewing and/or providing input regarding existing Standard Operating Procedures (SOPs), controlled forms and policies. Support internal compliance initiatives as required under Health Canada regulations and guidance. Provide quality support during regulatory inspections and third-party audits. Assists in developing and writing SOPs, protocols, and preventive control plans, ensuring compliance with the Cannabis Act and GPP/GMP. Other tasks as assigned.Knowledge and Experience: Minimum 1 year of relevant experience is required Bachelor's Degree in Chemistry/Biochemistry/Biology/Food Science/Pharmacy other related science Experience working in a regulated environment, pharmaceuticals, food, and/or NHP manufacturing Experience with Quality Management Systems (QMS) is essential; with experience with electronic QMS systems preferred Experience in Preventative Control Plans, Investigations, Root Cause Analysis and Risk Management will be an added advantage. Ability to apply critical thinking and problem-solving skillsRequired Competencies: Excellent written and verbal communication skills High attention to detail is essential Able to read, understand and interpret various regulatory requirements Able to apply regulatory interpretations into operational controls Able to work individually and as part of a team Able to multi-task efficiently and balance priorities in a fast-paced environment Excellent organizational skills Experience in training, coaching and mentoring employeesJob Types: Full-time, PermanentSchedule:

• 8 hour shift