Quality Specialist

Edgewell is not just a company, but a vibrant global community of 6,800 visionaries, doers, and makers. Our family of over 25 personal care brands serves people in more than 50 countries. We are dedicated to infusing joyfulness into every aspect of our work. Our pledge goes beyond our products, with our fundamental value of People First guiding us to foster a diverse, inclusive, and respectful environment where every team member can flourish and celebrate our shared achievements.

Position Summary

The primary responsibility of the CA Quality Specialist is to ensure the Quality System’s continuing excellence and compliance to Health Canada’s requirements in Canada. The incumbent will ensure ongoing compliance to all applicable Health Canada DIN/NHP and Device regulations, ensure all compliance plan deliverables are achieved, maintain all operations in full inspection-ready fashion, foster a mindset of continuous quality improvement, and be a leading voice in sustaining a culture of quality & excellence.

This is an onsite position at our Milton, Ontario facility with the opportunity for one day per week to work remotely.

Universal Accountabilities

• Ensure compliance to all Health Canada DIN/NHP and Medical Device GMP requirements.
• Ensure the quality systems are implemented and followed at the location (e.g. temperature monitoring, calibration program, document control, product testing, specifications, control procedures, etc.).
• Collection and maintenance of retention samples.
• Inspection and sampling of Finished Goods and/or Raw Materials.
• Prepare and Review “Release packages” .
• Processing of Consumer Complaint samples.
• Initiate nonconformances or deviations when issues occur.
• Produce corrective and preventative actions (CAPAs) and related quality metric reporting, ensuring quality investigations are closed in a timely manner.
• Initiate, implement and track changes through Change Controls.
• Participate in internal quality system and GMP inspections, prepare report of findings and corrective action report as required to ensure compliance.
• Collaborate with multidisciplinary teams as needed.
• Act as Canadian Release agent in the absence of EPC Quality Manager for Canada
  
  

Specific Accountabilities

• Maintain knowledge of current Health Canada GMP regulations (i.e GUI-0001, 0002, 0069 etc.)
• Update SOPs as needed .
• Liaison among Edgewell sites globally.
• Keep evidence and documentations as required by Regulations and internal procedures
  
  

Environmental, Health And Safety Responsibilities

• Work in compliance with Ontario Occupational Health and Safety Acts and Regulations.
• Work safely as required, following environment, health and safety policies and procedures, including the use of personal protective equipment, safety equipment/devices, and guarding and following safe work practices.
• Immediately report workplace hazards or occupational injury/illness to a team leader/supervisor.
• Report any missing or defective equipment or protective device that may be dangerous.
• Report or raise any perceived workplace harassment, discrimination or violence concerns.
• Actively participate in all health and safety initiatives and activities, including incident investigations, safety meetings and training.
  
  

Required Skills And Experience

• A Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a science related field. Alternatively, a diploma, certificate or other evidence of formal qualifications awarded on completion of a course of study from a college or technical institute in a science related field. (as per regulations)
• Minimum of 1-2 years of experience in Quality System in Canada with proven successful track record in a Drug/ Cosmetic/ NHP product company (as per regulations)
• Robust Knowledge of (but not limited to) GUI-0001 , GUI-0002, GUI-0005, GUI-0069, GUI-0080, GUI-0102
• Knowledge of (but not limited to) SOR/ 98-282, ISO 13485 and ISO 22716
• Knowledge of safe work practices and Ontario Health and Safety Act.
• Proficiency with various computer software (i.e. SAP, Trackwise, Microsoft Office) programs and use of audiovisual tools.
  
  

Preferred Skills And Experience

• Results oriented analytical thinker with strong problem-solving abilities.
• Collaborative approach with the ability to influence the decision-making process.
• Excellent interpersonal and communication skills at all levels both within and outside the organization.
• Strong initiative and organizational and project management skills.
• Ability to successfully work within and promote a team environment.
  
  

Working Relationships

• Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, technical support groups) as well as other value streams.
• External contacts: Consultants, contract laboratories, research organizations – technical partnerships such as trade organizations.
  
  

Work Environment

• Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
• Work schedules that vary from typical business hours.
• Exposure to health risks or conditions that may require the use of Personal Protective Equipment.
• Must be able to travel to off-site locations for meetings; occasional overnight travel required.
• Occasional work to match production hours, might look like 5-10 hours in the evening or weekend.
• Work from Home - 1 day per week, with flexibility depending on work load that requires on-site activities.
  
  

Quality Responsibilities

• Colleagues are responsible for their own quality and that of colleagues within their span of control.
• Colleagues are responsible to follow all established Quality procedures and instructions.
• Colleagues are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
• Colleagues are responsible for adhering to applicable Health Canada’s Good Manufacturing Practices work rules as they relate to job-specific duties.
  
  

Supplemental Information

This description is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and employees, but it does not purport to be an exhaustive list of all the elements of the job. Management reserves the right to modify and description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet the production, scheduling, or staffing needs.

Edgewell endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment & selection process.