Quality Systems Investigator

Summary:
Under the direction of the Quality Systems Supervisor - Investigations, the Quality Systems Investigator (12 months term position) is responsible for investigations and management of 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 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.

**Responsibilities**:

- 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.
- Project Management:

- Participate in cross-functional teams on process control, improvement, and optimization projects; as well as participate in other continuous improvement projects.
- Audits:

- Participate in internal, external as well as Regulatory audits.
- Performs other related duties as assigned by Management.

**Experience**:

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

**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.

Physical Demands:

- Prolonged sitting, some walking
- Working on a computer
- Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management’s assignment of essential functions, it does not prescribe or restrict the tasks that may be assigned._