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DNA Genotek: Quality Coordinator

DNA Genotek

This is a Full-time position in Gatineau, QC posted February 18, 2021.

OverviewFacilitates and coordinates quality assurance activities, including lot release of internal products, issuance of Certificates of Analysis, issuance of Certificates of Conformance and initiation and management of Nonconformance Reports (NCRs), CAPAs and changes associated with these processes.

Supports the Returned Materials Authorization (RMA) process.

Liaises with internal DNA Genotek departments to facilitate and coordinate activities associated with these processes.

Investigates customer complaints associated with these processes.

Supports external and customer audits as neededResponsibilitiesConducts lot review and release for internal products Prepares and issues Certificates of Analysis for internal products, such as chemistries Prepares and issues Certificates of Conformance for finished goods lots, as required Supports the Return Material Authorization (RMA) process.

Ensures that RMAs are processed in a timely manner Revises and updates associated QMS documents as needed.

Supports the customer complaint process, as associated with daily activities, ensuring timely completion of complaint investigations, as assigned Supports the Label Masters process, as a back-up Initiates, owns and investigates Nonconformance Reports surrounding the following processes:-Certificate of Analysis (CoA)-Certificate of Conformance (CoC) Label Master (as back up) Returned Materials Authorization (RMA) Ensures assigned nonconformances are thoroughly and timely investigated Ensures assigned nonconformances and CAPAs are closed in a timely manner, as related to risk.

Supports other QA activities as directed by Quality Management as needed: Quality Metrics trending Continuous improvement of quality-related processesQualificationsEDUCATION: Degree or Diploma in a Science or Engineering discipline, or an equivalent combination of relevant job experience, training and knowledge.

Recognized Quality Assurance/Quality Inspection certifications such as ASQ CQI or CQT are an asset.

Experience in participating in Quality Systems and Regulatory audits/inspections is an asset.EXPERIENCE: Minimum of 2 years in a quality role Experience performing lot release activities Experience in a lab or chemical manufacturing environment Experience in writing quality investigations is preferred Knowledge of QA terminology, investigation tools, and methodologies Operations and/or customer support experience is an asset Experience and working knowledge of regulatory and industry standard requirements, e.G.

ISO 9001,13485 and 21 CFR Part 820 Strong planning, organization and time management skills Well-developed communication skills, both oral and written Well-developed software skills, i.E.

knowledge of Microsoft applications (Excel, Access, Power Point, etc.) or equivalent required.

CORE REQUIREMENTS: Organized Dependable Reliable Motivated Positive Integrity Analytical Team-oriented Keen attention to DetailAt DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment.

Accommodations are available to support prospective employees during the recruitment and hiring process.

Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.