Quality Assurance Coordinator

Company Overview

Jamieson Wellness Inc.
is Canada's leading health and wellness company, driven by a purpose to inspire better lives, 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 ***

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.

1. OVERALL RESPONSIBILITIES

The QA Coordinator will support all Quality Systems to ensure quality manufacturing of products as defined by current Good Manufacturing Practices (cGMP).
Provide assistance to other departments concerning quality and GMP issues.Ensure appropriate compliance to all relevant regulatory requirements.
Accountable for timely release of materials and products to cGMP standards.
Meet Jamieson Wellness (JWEL) Quality standards.
This is an 16 month contract role.

2.
DUTIES AND RESPONSIBILITIES

• Act as a qualified person (as defined under Health Canada drug section C.02.006 and Nutritional GUI-0001 section 51 of GMP guidelines and section 1.5 of WHO GMPs) in the release of finished product.
• Follow and maintain GMPs and GLPs for the facility.
• Utilize systems including ERP, LIMS and QMS for day to day functions.
• Work in a team environment to ensure all Quality job functions are covered.
• Support QC Samplers/Technicians on site for LIMS job tasks.
• Support RD on site with LIMS tasks, including RD samples, testing, specifications and inventory management.
• Assist other departments on handling and providing direction on quality related issues.
• Audit batch records and approve release of materials and products in the ERP system.
• Review and disposition material and product CofAs in the LIMS system.
• Responsible for handling and coordinating Out of Specification investigations in LIMS.
• Track and manage Material retest/expiry program, including rejection process.
• Prepare, revise or approve master formulas, master batch records and material/product specifications.
• Lead specification update projects including supplier alignment.
• Coordinate Environmental monitoring and trending results.
• Review and trend Purified Water System testing results.
• Perform production batch adjustments, one-time-specification changes, and review lot continuations.
• Prepare rework/reclaim masters.
• Coordinate and/or perform formal AQLs and carton AQLs.
• Conduct internal audits, complete internal audit reports and track corrective actions to completion.
• Responsible for rotational facility daily inspections.
• Assist with external audits.
• Prepare and review documentation for facility customer, third party certification and government audits.
• Maintain up-to-date and accurate QMS systems/databases including deviation investigations, complaints, change control and CAPA.
• Investigate, trend and complete reports for deviations, complaints and OOS.
• Complete RCA investigations and justifications for closure with scientific rationale and risk-based decision making.
• Create and implement CAPA plans and conduct formal CAPA Effectiveness checks.
• Initiate continuous improvement training notices and operational communications.
• Responsible for change control review and approvals and executing change control deliverables.
  
• Back up to Quality Associate duties including SOP system, training files, document filing & archives, quality metrics and temperature/humidity monitoring.
• Conduct new hire GMP orientation training.
• Write or revise SOPs and controlled forms.
• Review production logs, QC logs & facility records including calibration, equipment, facility, temperature/RH, preventative maintenance, pest control, and sanitation records.
• Prepare or review RMQ (raw material or component item qualification packages).
• Prepare or review VQ (vendor and contractor site qualification packages)
• Prepare product Annual Product Reviews (APR) and Trend reports.
• Review Validation protocols, data and reports.
• Prepare technical documents and study protocols.
• Prepare technical document requests.
• Maintain ordering of lab supplies.
• Working in compliance with the company's Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities Procedure.
• Other duties and projects as required.

3.
QUALIFICATIONS AND BEHAVIORAL REQUIREMENTS:

• Minimum Bachelor's Degree in Science related field from an accredited post secondary institution.
• Minimum 2 years practical Quality department experience in a pharmaceutical, nutritional, food or health products manufacturing environment.
• Comprehensive knowledge of manufacturing operations and cGMP and GLP.
• Familiar with USP, AOAC, FCC and other compendia standard used in the food, nutritional and drug industry.
• Experience in softgel and liquid manufacturing environment an asset.
• Comprehensive knowledge of pharmaceutical, food and natural health product regulations.
• Excellent communication and written skills
• Excellent problem-solving skills.
• Proficient with computers including Microsoft 365 application.
• Experience with ERP, LIMS and QMS an asset.
• Team oriented focus.
• Self-starter and critical thinker.
• High work ethic standards a must with the ability to multi-task.
• Ability to work with minimal supervision.
• Able to work shift work to provide job coverage as required.
• Able to work overtime to meet production/customer deadlines and complete projects by due dates.
• Able to lift at least 25 lbs for associate duties.