Summary:

Under the direction of the Quality Operations Supervisor, the Quality Ops Inspector II is responsible for operational quality during production by conducting in-process quality inspections of manufactured bulks and Finished goods, reviewing in-process Batch production documentation, and managing and escalating any non-conformances.

The Quality Assurance Inspector II must act as a Quality consultant to Operations, being a key point of contact between all departments for quality issue escalation and resolution. To promote fitness of the systems and processes employed in their area of responsibility, they will provide 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 Assurance Inspector II 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, Warehouse and other Quality Departments.

The Quality Assurance Inspector II must have a broad understanding of Quality requirements as outlined by Regulatory Authorities and apply that understanding to the execution of their responsibilities.

Responsibilities:

• Production Quality Oversight:

o Identifying, communicating and reporting any non-conformances, ensuring imminent containment activities are made.

o Providing quality consultation to resolve any lot quality issues identified by the Operations department.

o Assisting and supporting in the assessment and investigations of deviations, ensuring they are escalated to management and any related tasks assigned are closed off within the target timeline.

o Providing QA technical support including but not limited to: SOP clarifications as they pertain to IVC VITAs procedures and the GMP’s, process deviations, and process Change controls.

o Assisting and coordinating the rework of non-conforming lots.

• Review:

o Reviewing and approving executed Batch Records, NIFs, and BOM/Routing changes.

o Reviewing facility audit trails

• Project Management:

o Participating in cross-functional teams on process control, improvement, and optimization projects; as well as participating in other continuous improvement projects.

• Training:

o Monitoring GMP/SOP Compliance for the facility

o Training Operations personnel on the importance of following SOPs

o Mentoring of Quality Ops Inspector Is

• Audits:

o Participating in internal, external as well as Regulatory audits.

• Performs other related duties as assigned by Management.

Qualifications & Experience Required:

• 3+ years of work experience in a Health Canada-regulated environment (i.e., Food, Pharmaceutical or Medical Device Industry)

Education, Certification, Licenses & Registrations:

• Diploma or degree in a technology, science, pharmacy or other health-related discipline (or equivalent combination of education and experience)

• Accredited GMP certification is an advantage

Skills

• Proven working knowledge of Health Canada regulatory and GxP compliance requirements.

• 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 work effectively with individuals at all levels of the organization.

• Excellent English written and oral skills.

• Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)

Physical Demands:

• Manual dexterity, prolonged standing and walking

• Occasionally lift 0 - 15 pounds

• Must be able to work shifts (7am – 3pm, 3pm – 11pm, 11pm – 7am)

• Working on a computer