The Coordinator, Quality under the direction of the Manager, Quality, coordinates the implementation and maintenance of the Quality Management System. The successful incumbent also assists with the Risk Management Program, the Internal and External Auditing Program and supports business development proposals. The Coordinator, Quality also participates with special projects, including the development of policies, procedures and education materials across all Bayshore Specialty Pharmacies.
DUTIES AND RESPONSIBILITIES
- Assist with contracts’ requirements and customers’ expectations across all BSRx departments, divisions and locations.
- Assist with Policies, Procedures and SOPs and assigns them across all departments respectively.
- Coordinates the maintenance of Policies and Procedures, assisting with updating them accordingly and ensure they are shared with employees, read and understood and implemented by all.
- Assist with the development of the quality control processes.
- Assist with the compliance with all regulatory bodies (OCP, NAPRA, ISO, Health Canada and others).
- Coordinates Quality practices across all of BSRx facilities.
- Assist with SLA sharing across departments and ensures smooth production flow.
- Work on improving production efficiency and reducing waste under the direction of the Manager, Quality.
- Ensure adherence to health and safety guidelines as well as legal obligations.
- Keep accurate documentation and perform statistical analysis.
- Assist with ensuring a solid survey process is in place, collect feedback, show trends and work on preventative action plan when needed.
- Facilitate the QMR process; meeting minutes, assignments, follow up and ensures that events are being directed to the most appropriate person and all investigations are done on time with proper root cause analysis and preventative action plan.
- Assist with responses to customer complaints putting in containment actions, full analysis, and coordinating short-term and long-term countermeasures.
- Assist with creating a program for the implementation and sustainment of a continuous improvement culture and keep records of all initiatives implemented.
- Ensure that all necessary systems and procedures are in place to satisfy all customer requirements and audits
- Coordinate the introduction of new systems and procedures where appropriate.
- Coordinate training interventions to meet quality management standards.
- Act as secondary contact during internal, client, third party or regulatory body audits.
- Document, track internal audits/quality assurance activities, and follow-up on action items.
- Assist with the preparation of reports to communicate outcomes of audit findings/quality activities.
- Coordinate audit responses regarding deviations related to audit findings.
- Participate in activities geared towards process and/or document improvement. This may include process optimization, assisting with the development or revision of program specific protocols and/or revision of policies and procedures.
- Gather data for review/analysis
- Participate in proactive Health & Safety activities while performing all duties. Notify immediate Supervisor of any Health & Safety risks or concerns.
- Maintain confidentiality of client and corporate information at all times.
- Run spot audits daily to ensure compliance.
- Manage document control and ensure it’s up to date and all documents are saved and readily accessible.
- Communicate with personnel at all levels, internally and externally to the Company, in relation to Quality matters.
- Complete other tasks as requested.
The Coordinator, Quality reports directly to Manager, Quality.
Bachelor’s degree preferably in a health or business related field
At least three years experience preferably in health care; experience in implementing policies and processes, reports and presentations.
Other Skills and Abilities
Strong interpersonal skills, ability to work independently and as part of a team; demonstrated ability and competency in Windows software, exceptional organizational skills and ability to meet deadlines; strong commitment to continual learning. Ability to communicate in French is a definite asset. Demonstrates basic clinical analysis and informatics competencies E.G. device, application and information communication technology basic skills.
STANDARDS OF PERFORMANCE
The Coordinator, Quality must demonstrate ongoing competency in completing all expected duties and responsibilities of this job description as well as specific goals and objectives that are agreed to.