QA Reviewer L

2 weeks ago

Winnipeg, Canada Vita Health Products Inc Full time

Summary:
Under the direction of the Quality Assurance Operations Supervisor, the Quality Assurance Reviewer is responsible for the review and disposition of all items in the IVC Vita Health facility. This includes in-house finished good, purchased finished goods, in-house manufactured bulk, purchased bulk, raw material, packaging componentry (printed and non-printed) and returned finished goods.

The Quality Assurance Reviewer is expected to provide feedback and updates to both internal as well as external customers. This includes providing internal and external customers with requested documentation such as Certificates of Analysis and Certificates of Manufacture.

**Responsibilities**:

- Review and Release of Starting Materials, Manufactured and Packed Items by IVC Vita Health & Items Received as Bulk, Intermediate Bulk and Finished Packed Products:

- Conduct verifications on the documentation associated with received raw material, printed and non-printed packaging components.
- Conduct reviews on executed batch records and QC Laboratory records and all associated documentation Verify that Production and QC documentation are completed in compliance with approved SOPs.
- Ensure changes/ deviations in production or quality control have been approved according to QMS.
- Identify, report and resolve identified discrepancies and non-conformances. Initiate deviations, provide directions for any corrective actions that are required and complete any related tasks assigned.
- Verify the lot meets the release requirements are met for a release decision. Conduct the ERP system (M2M) transactions for the release of the lots.
- Collaborate with Product Owners, Developers and other QA team members as required on Acceptance criteria that need to be tested.
- Conduct any other M2M transactions as required.
- GMP Documentation:

- Compile release documentation for customers (Certificate of Analysis, Certificate of Manufacture and Certificate of Packaging) and provide to both internal and external customers.
- Maintain and file all associated documentation appropriately for accessible retrieval.
- Provide the business with batch specific review and release status updates as required.
- Liaise with internal and external customers as required.
- Collect information for feedback to the daily direction setting priorities or others such internal meetings, as required.
- 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 years’ experience in a GMP regulated environment and in quality assurance or manufacturing function.
- Minimum 1 years hands on experience working experience in production environment.
- Minimum 1 years work experience in the Food, Pharmaceutical or Medical Device Industry.

Education, Certification, Licenses & Registrations:

- Educated to a degree level (technology, science, pharmacy or other health related discipline) e.g. B.Sc. 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.
- Must demonstrate attention to detail, problem solving skills and decision
- making skills.
- Excellent English written and oral skills.
- Strong analytical skills and have the ability 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.
- Demonstrate ability to work effectively with individuals at all levels of the organization.
- Demonstrate a Client focused approach to work.
- Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
- Production and or Quality Control laboratory experience is an advantage.

Physical Demands:

- Prolonged sitting and walking
- Working on a computer
- Must be able to work shifts
- 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._

**Shift - **Evening Shift 03:00 PM to 11:00 PM

**Application Deadline: March 01, 2024

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