QA Coordinator, Contract - Windsor, Canada - JAMIESON WELLNESS INC

JAMIESON WELLNESS INC
JAMIESON WELLNESS INC
Verified Company
Windsor, Canada

3 weeks ago

Sophia Lee

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Sophia Lee

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Description

Company Overview

OVERALL RESPONSIBILITIES


The Quality Assurance Coordinator will perform quality audits and in-process checks on Jamieson manufacturing and packaging operations, thus ensuring that quality manufacturing as defined by GMP is maintained.

In addition, the Quality Assurance Coordinator will assist the Quality Assurance Supervisor in supporting systems to ensure quality manufacturing as defined by Good Manufacturing Practices (GMP) relating to natural health and pharmaceutical products.

Ensure appropriate compliance to all relevant regulatory requirements.


DUTIES AND RESPONSIBILITIES

  • Act as the qualified person (as defined under section C of Good Manufacturing Practices Guidelines) in the disposition of bulk and finished product
  • Responsible for the annual review/trend reports (Critical Deviations, Rejection, etc.)
  • Responsible for investigating quality related deviations
  • Responsible for conducting Internal Audits
  • Responsible for SOP management
  • Responsible for review of Certificate of Analysis
  • Participate in Change Control approval process
  • Participate in CAPA investigations and write investigation reports
  • Quality Assurance oversight in OOS lab investigations and responsible for disposition
  • Report and respond to quality process deviations in an expedient manner
  • Provide assistance for other departments concerning quality related issues
  • Annual Product Reviews for customers upon request
  • Review of manufactured bulk & packaging work orders
  • Review of contract manufacturing and packaging documentation
  • Perform random inprocess inspection of manufacturing operations
  • Perform random inprocess inspection of packaging operations
  • Monitor and maintain water purification system
  • Monitor all temperature and humidity recording devices locate in Jamieson's manufacturing facility
  • Maintain temperature and humidity devices as related to stability studies
  • Responsible for the verification and disposition of returns
  • Check calibration of various inprocess testing equipment including balances, hardness tester, friability apparatus and thickness gauges
  • Maintain calibration logs and take appropriate corrective action when necessary
  • Working in compliance with the company's Health & Safety Policies/SOPs including but not limited to the Safety Responsibilities Procedure
  • Responsible for investigating Consumer Complaints
  • Responsible for the governance of GMP documents
  • Will comply with Good Manufacturing Practices in all GMP sensitive areas of Jamieson Laboratories Ltd. facilities
  • Perform other related duties and projects as assigned

QUALIFICATIONS/BEHAVIORAL REQUIREMENTS

  • Minimum of a Technical Diploma in Chemistry, Biology, Microbiology, Biochemistry, Pharmacy or an appropriate Life Science from an accredited postsecondary institution and minimum of two (2) years in practical experience
  • Comprehensive knowledge of manufacturing operations
  • Comprehensive knowledge of pharmaceutical, food and natural health product regulations in Canada
  • Excellent communications
  • Excellent problem solving skills
  • Proficient with Microsoft Word, Excel, Access
  • Ability to work with mínimal supervision
  • Team oriented
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OUR VALUES-
_INTEGRITY _
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We do what is right even when it's not easy
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We demonstrate humility in everything we do
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We courageously stand up and support our diverse heritages, traditions, experiences, beliefs and styles
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We allow ourselves to be vulnerable, admit mistakes, learn from them and move forward-
_TRANSPARENCY _
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We respectfully communicate honestly and directly in a timely manner
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We proactively seek diversity of ideas and provide real feedback in the interest of improvement and development
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We constructively share and respect each other's opinions and ideas to enable sound decision-making at all levels
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We encourage differing point of views and productive debate to develop the best solutions-
_TEAMWORK _
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We constructively challenge ourselves and others to achieve desired outcomes
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We demonstrate mutual respect, inspire trust and promote equality
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We collaborate toward common vision and objectives across all persons, levels, functions and locations as one company
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We recognize, celebrate and value each other's differences, styles and contributions as one of our greatest strength
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We lead with a passion for winning together-
_ACCOUNTABILITY _
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We take personal ownership and pride in everything we do
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We demonstrate a bias for action
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We challenge the status quo constantly seeking to improve
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We eliminate barriers and bias to empower others to achieve our goals
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We are accountable to build an environment free of bias in regard to race, gender, sexual orientation, and all other types of discrimination-
_ENTREPRENEURSHIP _
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We are empowered to pursue opportunities that will have great impact
- **Our curiosity dri

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