Quality Systems Investigator

Under the direction of the Supervisor Quality Systems - Investigations, the Quality Systems Investigator is responsible for Complaints, Deviation and related CAPA management.

The Quality Systems Investigator must act as a Quality consultant to Operations, being a key point of contact between all departments to promote fitness of the systems and processes employed in their area of responsibility, providing technical oversight and serve as an escalation point where support and intervention is required within the company, to generate reliable, accurate and complete data.

The Quality Systems Investigator is expected to possess or obtain sufficient knowledge to provide input or approval of proposed changes to GMP systems during which will interface closely with other cross-functional groups such as Manufacturing, Packaging, Maintenance, Product and Process Development and Warehousing.

Duties will include:
**Deviation Management**:

- Lead and / or support thorough investigations of identified quality issues ensuring effective corrective and / or preventive actions are identified and implemented in a timely manner.
- Assist, support and drive departmental Subject Matter Experts in the completion of deviation actions in a timely manner.
- Provide assistance and support during investigations with Vendors or Supplier Development and Procurement Management for issues associated with raw materials, contract manufacturing and components.
- Conduct quality risk assessments following established risk procedures for identifying areas for improvement.
- Compile and assist with the review of investigation reports for completeness, recommended constructive changes as appropriate.
- Identify & review the initiation, execution and escalation of related CAPA.
- Author and review standard operating procedures related to deviation and project management systems.
- Perform assessments of any given quality system to determine the effectiveness and dependability of such system.

**Complaints Management**:

- Coordinates, complies data and prepares complaint investigation reports or drug products which includes data collection, analyses and initial report preparation.
- Communicates information related to complaint investigations from customers, pharmacists, vendors, or customer service. Communicates with other Vita Health staff regarding complaints and metrics.
- Participates in preparation of trending reports; including Histograms and Pareto Charts for presentation to management. Assists in the preparation of Quarterly complaint reports.
- Reviews and recommends updates to relevant SOPs, forms and other documents as required.
- Attends meetings relevant to complaint investigations and/or metrics.
- Participates in internal and external audits as a Subject Matter Expert on specific complaint files.
- Other duties as assigned by management, e.g. filing

**Preferred Skills**:

- Working knowledge of Health Canada regulatory and GXP compliance requirements
- Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
- Problem solving and statistical skills using quality tools (Pareto analysis, statistical process control, etc.).
- Strong analytical skills; able to use data, communicate key trends, develop and execute continuous improvement plans.
- Strong organizational skills; ability to work with cross-functional groups to implement improvements
- Ability to manage multiple tasks and work well under pressure
- Ability to work independently or in a team environment, take initiative, and have a flexible approach with respect to work assignments and new learning.
- Ability to lead groups, demonstrate and foster teamwork in a project setting.
- Demonstrate ability to work effectively with individuals at all levels of the organization.
- Demonstrate a Client focused approach to work.

Demonstrate ability to use influencing skills to accomplish goals and objectives.

**Required Experience**:

- Minimum 5 year work experience in the Food, Pharmaceutical or Medical Device Industry.
- Minimum 3 years working in a GMP regulated environment.
- Minimum 2 years hands on experience working experience with Quality Systems involved with Document and Deviation management.

**Education, Certification, Licenses & Registrations**:

- Bachelor’s in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field preferred.
- Accredited GMP certification such as ASQ CQE or CQM preferred

**Job Types**: Full-time, Permanent

**Benefits**:

- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Paid time off
- Store discount
- Vision care

Schedule:

- Day shift

Application question(s):
**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- food, pharmaceutical, or medical device industry: 5 years (preferred)
- GMP regulated environment: 3 years (preferred)