Quality Systems Investigator

Under the direction of the Quality Systems Supervisor - Investigations, the Quality Systems Investigator is responsible for investigations and management of Complaints, Deviations, and relevant CAPA activities.

The Quality Systems Investigator acts as a Quality consultant to Operations, being a key point of contact during investigations and assigned projects, to promote fitness of systems and processes employed in their area of responsibility, providing technical oversight and serving as an escalation point where support and intervention is required when issues associated with deviations and / or complaints are identified.

The Quality Systems Investigator is expected to possess or obtain sufficient knowledge to provide input to other (cross-functional) groups such as Manufacturing, Packaging, Maintenance, Product and Process Development, and Warehousing during the approval and implementation of proposed corrective / preventive actions

The Quality Systems Investigator must have an understanding of the Quality requirements as outlined by Regulatory Authorities and applying that understanding to the execution of their responsibilities.

Responsibilities:

• Customer Complaints Management:
  • Conduct and complete complaint investigations in a timely manner, as defined by procedures.
  • Coordinate and work with SME's to identify root causes as applicable.
  • Login complaints into database, track, and manage investigations through to completion.
  • Identify & review the initiation, execution and escalation of related CAPA.
  • Track implementation of complaint CAPA's through to completion.
  • Escalate risks or challenges involving investigation completion and / or CAPA implementation.
  • Compile and assist with the review of investigation reports for completeness, recommended constructive changes, as appropriate.
  • Author and review standard operating procedures related to complaint systems.
• Deviation Management:
  • Lead, support, and complete thorough investigations of identified quality issues, ensuring root causes are appropriately assessed and effective corrective and / or preventive actions are identified and implemented in a timely manner (after the due date) as defined by procedures.
  • Assist, support departmental Subject Matter Experts in the completion of deviation actions in a timely manner.
  • Assist with the review of QSI I investigation reports for completeness and recommend constructive changes as appropriate, when assigned by Supervisor.
  • Identify & review the initiation, execution and escalation of related CAPA.
  • Author and review standard operating procedures related to deviation systems.
  • Perform assessments of any given quality system to determine the effectiveness and dependability of such system.
  • Ensure Supplier investigation requests (SCAR's) are issued to Vendors / Suppliers, via Procurement / Buyers, for issues associated with raw materials, contract manufacturing and components.
  • Track SCAR's through to completion.
• Project Management:
  • Participate in cross-functional teams on process control 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 with Quality Systems including product non-conformance management.

Education, Certification, Licenses & Registrations:

• Bachelors in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field preferred.
• Accredited GMP certification such as ASQ CQE, CQA, 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 / root cause analysis skills; and experience with quality / statistical 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.