Quality Assurance Specialist

Jamieson Wellness Inc.; Windsor; On-site; CAD 60,000 - 90,000; Full time

Job summary

A leading health and wellness company is seeking a Quality Assurance Specialist to oversee quality processes and ensure compliance with GMP standards. The ideal candidate should hold a Bachelor of Science degree and possess at least three years of experience in QA roles. Responsibilities include quality monitoring, collaboration with various departments, and maintaining documentation integrity. Join a team committed to excellence in health and wellness products and help drive their industry-leading reputation.

Qualifications

• Minimum three years of practical experience.
• Good knowledge of GMP regulations.
• Ability to learn complex documentation related to quality.

Responsibilities

• Ensure quality of finished products before sale.
• Conduct root cause analysis for deviations.
• Collaborate with departments for quality assurance.

Skills

Problem solving

Critical thinking

Attention to detail

Education

Bachelor of Science

Tools

Quality Management System

Statistical Process Control Software

ERP software

Job description

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Company Overview

Jamieson Wellness Inc. is Canada’s leading health and wellness company with a purpose of inspiring better live every day.

Established in 1922, Jamieson is our 100 years old heritage brand, which is recognized as Canada's #1 consumer health brand. In addition, we also market and manufacture a series of leading specialty supplements brands under the youtheory, Progressive, Smart Solutions, and Iron Vegan brands.

On top of our outstanding brand portfolio, Jamieson Wellness Inc. has been recognized as one of the top ten most reputable companies in Canada and is well regarded for our industry leading commitment to quality – exemplified through award-winning innovations and meeting of rigorous manufacturing certification standards. And, Jamieson is no longer just a Canadian success story, as our brands are established and growing rapidly in more than 50 countries around the world. For more information, please visit www.jamiesonwellness.com

Our Jamieson Diversity and Inclusion Statement

At Jamieson Wellness, we cherish diversity, equity and inclusion and we know we must constantly listen, learn and take action to ensure these principles remain embedded in our culture. We encourage everyone to bring their whole selves to work and celebrate the differences that make us unique. We are accountable to build an environment free of bias in regard to citizenship, race, place of origin, ethnic origin, colour, ancestry, disability, age, creed, sex / pregnancy, family status, marital status, sexual orientation, gender orientation, gender identity, gender expression, and all other types of behaviours that are not conducive to an inclusive environment. We hold ourselves and all stakeholders to a high standard of diversity equity and inclusion, because anything else is unacceptable.

• OVERALL RESPONSIBILITIES

The Quality Assurance Specialist is Responsible for the coordination, control, update, and maintenance of all specific areas of core Quality Assurance Processes and Systems. This role is primarily responsible for assuring the quality of all the manufactured products to finished goods through the compliance of the assigned GMP function and activity.

This role is primarily responsible for assuring the quality of all the manufactured products to finished goods.

• Leader of the Finished Goods Process and Product Quality
• Assuring the GMP Compliance of the assigned GMP function and activity
• Drives the culture of Proactive Quality by integrating into the process and product quality, problem solving and resolution, in collaboration with other departments, the mindset of quality.

2. DUTIES AND RESPONSIBILITIES

• Under the responsibility of the Quality Assurance Manager or designate act as the qualified person (as defined under section C.02.006 of Health Canada GMP guidelines, GUI-00001; Section 51 of Health Canada NNPHPD GMP Guidance Document; Section 1.5 of WHO GMP Principles). Responsible for assuring the quality of the finished product is suitable before the product is made available for sale.
• Under the responsibility of the Quality Assurance Manager or designate acts as and is responsible to maintain and ensure compliance of the specific area related to licensable activities under GMP regulations and core quality processes as Deviations, Nonconformances, Out-Of-Specifications, Root cause analysis, consumer complaints, CAPA, Recall, among others.
• Act as the designated responsible person in the processing, evaluation, monitoring, and control of Change Control Processes.
• Ensure Material and Product Masters creation and revisions are completed in a timely manner to meet production timelines following Change Control Processes.
• Approve Formula Specifications and Testing Specifications for materials and products (as applicable to each site)
• Prepare and ensure the completion of the Site Audit Schedule.
• Ensure lot disposition decisions in ERP for materials and products meet TATs, production, and customer needs (as applicable to each site)
• Collaborate with other stakeholders in the evaluation of deviations occurring in manufacturing and packaging activities manufacturing and packaging activities as well as deviations occurring in QC laboratory due to OOS.
• Prepare and ensure application of Root Cause Analysis techniques in the active resolution of deviations and non-conformances.
• Responsible for actively applying proven techniques and quality knowledge to evaluate processes, documentation, product inspections, review final AQL Inspection results of the WIP / FG, measurements, process performance, records, and data. Responsible to prepare Annual Trend Reports as assigned.
• Analyze statistical data, trends and patterns across multiple quality and operation areas. Utilize a risk assessment approach to define disposition, action plans, operation improvement within the area of competence.
• Aid other departments to continuously improved adherence to Good Manufacturing Practices, as defined in local and international regulations.
• Aid QC Laboratory to continuously improve adherence to Good Laboratory Practices.
• Report quality, compliance, or internal process deviations in an opportune manner to all applicable stakeholders.
• Collaborate and review reports from the evaluation of the purified water system used in the GMP operation, Environmental Monitoring data at the stated frequency. Define actions and escalate excursions or trends as required.
• Monitor the environmental temperature and humidity data on regular basis. Define actions and escalate excursion events as required.
• Monitor and ensure compliance of the Calibration / Verification of Equipment which has influence on the manufacturing and packaging operations.
• Responsible for a timely definition, monitoring, and effectiveness check of Corrective and Preventive Actions.
• Responsible for preparing sound and concise reports for deviations related to the quality investigations.
• Responsible for / guide and review reports for deviations related to the Quality Assurance part pertaining out-of-specification and out-of-trend results.
• Responsible for the verification and disposition of returns due to non-compliance bulks and finished goods.
• Aid other departments concerning quality-related issues.
• Supports the Equipment / Process Qualification, Cleaning and Sanitization validations. May review protocols and reports as required for the process or product category; participate in the execution of validation activities as required.
• Utilize Quality Systems including QMS, ERP, LIMS, among others.
• Populate Quality Metrics as required.
• Complete Vendor Qualifications and / or Raw Material Qualifications as required (as applicable to each site)
• Lead projects for major specification updates including supplier alignment, as required.
• Perform or review batch potency adjustment.
• Track retest and expiry date program and determine disposition of lots.
• Prepare Technical Documents and Study Protocols and Special Projects as required.
• Support Quality team and provide back up as required.
• Other duties and projects as assigned.
• QUALIFICATIONS AND BEHAVIORAL REQUIREMENTS :

Minimum Bachelor of Science degree from an accredited post-secondary institution. Prior experience in the field can be valued jointly with other type of post-secondary education.

• Minimum three (3) years of practical experience.
• Good knowledge of pharmaceutical, food and natural health product regulations in Canada and Internationally.
• Comprehensive knowledge of pharmaceutical, food and natural health product regulations in Canada and Internationally
• Highly skilled in problem-solving and resolution, critical thinking and decision making.
• Risk-based decision-making skills - capable to make quality dispositions based on the quality status of products; can decide on special releases (conditional releases & deviation approvals) to meet demands from the business.
• Good knowledge of manufacturing operations and GMP.

with Microsoft applications (Word, Excel, Power Point etc.), Quality Tools, Statistical Process Control Software applications, Quality Management System, ERP software as applicable.

• Ability to learn highly complex documentation, processes and tasks related to quality and compliance as defined by GMP guidelines.
• Excellent communication and writing skills.
• Technical knowledge in handling deviation investigation and change control, documents review and control, product releases, conducting internal product audits, handling customer issues, root-cause analysis (RCA / CAPA), troubleshooting, process validation.
• Excellent attention to details, and problem-solving skills.
• Able to commit to timelines in a fast-paced environment.

Seniority level

Seniority level

Associate

Employment type

Employment type

Contract

Job function

Job function

Quality Assurance

Wellness and Fitness Services

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Quality Assurance Specialist • Windsor, Windsor, Canada