Quality Systems Coordinator Jobs

Excellent project and data management skills and a keen attention to details

Experience in execution of internal audits and management of routine GxP inspections.

Manage ADCT Quality Event records, including Deviations, Change Controls, and CAPAs, to industry requirements

Support internal audit, inspection readiness, and inspection management activities

Other responsibilities as directed by manager

Ability to work independently and manage priorities in a remote setting while making sound quality/compliance-based decisions

Knowledge of aerospace quality standards and requirements, drawings,

Maintain Work Instructions/processes/procedures/QAPs/SOPs and airworthiness documentation related to DND requirements (F404 and J85).

Provide oversight of work instructions as well as upkeep of QAPs/SOPs and manuals to reflect off-site employee requirements

Experience with evaluating and implementing quality assurance tools and processes

Strong Microsoft Applications experience, including Word, Excel and PowerPoint

Excellent written & oral communication skills.

Experience in change management or lean transformation an asset.

Proven time management and organizational skills to work in a fast pace regulated environment and manage multiple projects concurrently.

Implement / maintain electronic documentation and learning management systems in collaboration with NC-HC sites

Support site internal project(s) and temporary assignment(s) as assigned by Quality Management.

Participate in Quality Risk Management to support GMP operations

Effective and professional interpersonal skills with abilities to influence others across multiple functions.

Lead and direct team members to assist in maintaining the Quality management system.

5+ years of related experience in quality.

ISO 13485:2016 Internal Auditor Certification.

Experience with data process and statistical analysis.

Excellent verbal and written communication skills.

Excellent attention to detail and organization skills.

3+ years of People Management experience.

Demonstrated experience in executing quality management systems within heavily regulated environments.

10 years of Quality Systems experience.

Strong knowledge of domestic and international quality standards, including ISO 9001, ISO 13485 and/or other applicable regulations.

Experience in the healthcare, medical device, or pharmaceutical industry.

Lead investigations of incidents and accidents according to company reporting procedures, ensuring thorough analysis and the implementation of preventive measures.

Experience working in quality management systems based on quality standards such as ISO 9001:2015 and API Q1.

Knowledge and prior experience working within API Q1 and ISO9001 Standards.

Good computer skills, including an understanding of Microsoft Office Suite programs.

Team player with good verbal and written communication skills, able to follow and understand

Minimum 2 years of direct QC experience in a manufacturing or machining environment.

Lead or internal auditor training or certification is an asset.

Ability to work with little or no supervision, Human relation skills, above average keyboarding skills, Knowledge of Microsoft Office.

Must establish good relations with the management team.

Ensures the validity of all training requirements related to the QMS and maintains the associated records.

Knowledge of regulatory & industry standards (AS9100, AS13100 & NADCAP).

In-depth familiarity with quality assurance systems, practices, and documentation, experience in manufacturing operation, experience in Internal Auditing.

Strong quantitative analysis skills, including the use of Microsoft Excel.

Good knowledge of electronic document management

Experience in ISO 9001: 2015 standard requirements and certification

Maintain and improve the Quality Management System (quality manual, procedures, forms, tools)

Strong Electronic Documentation Management expertise

Experience in Health & Safety (an asset) Personal & soft skills:

Drive and coordinate with line Managers quality processes updates based on Lessons Learned and KPIs

Construction industry (Concrete, Steel, Asphalt) knowledge and experience would be considered an asset.

Ability to liaise and form positive relationship with all levels of employees and management.

BSc Engineering in Civil or CET education an asset.

ISO 9001 Quality Control Internal Auditing Certification an asset.

1 year’ experience in infrastructure as a minimum.

Profound knowledge of Microsoft Word, Excel, Visio, Access, Power Point.

Strong attention to detail, organizational skills, and time management skills.

Performing Quality Kick-Off meetings with the supplier to explain project Quality Management.

Maintain a solid knowledge base of District Quality Manuals.

Understand requirements of ISO 9001 Standards.

Collaborating with the supplier to identify Quality requirements.

ASQ Audit certification is preferred.

Strong attention to detail, organizational skills, and time management skills.

Performing Quality Kick-Off meetings with the supplier to explain project Quality Management.

Maintain a solid knowledge base of District Quality Manuals.

Understand requirements of ISO 9001 Standards.

Collaborating with the supplier to identify Quality requirements.

ASQ Audit certification is preferred.

Knowledgeable and experienced in: Lean, Six–Sigma, Process Approach Mapping, Project Management Practices and Data Analysis.

Required Knowledge, Skill And Abilities

Develop the Management Systems strategy, demonstrating solid progress against plan.

Regulate, Control, and improve the quality of all processes throughout the business. Lead the team to achieve quality management system targets.

Facilitate integration of other business aspects within the QMS, such as Safety, environment, efficiency – Total Quality Management mindset (TQM).

Minimum 10 years of relevant experience within a Manufacturing environment in a similar capacity

Postsecondary education in engineering, construction management, or a related field.

Demonstrate planning, organizational, and time-management skills with the ability to multitask, prioritize own work, and work as a team.

Auditing project QMS to ISO 9001:2015 requirements

5 years proven experience in quality control on civil construction projects; Design experience is highly preferred.

Experience with healthcare projects is highly preferred.

Strong verbal and written communication skills.

Construction industry (Concrete, Steel, Asphalt) knowledge and experience would be considered an asset.

Ability to liaise and form positive relationship with all levels of employees and management.

BSc Engineering in Civil or CET education an asset.

ISO 9001 Quality Control Internal Auditing Certification an asset.

1 year’ experience in infrastructure as a minimum.

Above average computer skills utilizing MS office application.

Establishing, supporting, maintaining, monitoring QMS framework processes and robust quality systems management program in compliance applicable global CMC/GMP requirements

5+ years of quality system management experience in a GxP regulated environment

You are enthusiastic about applying your expertise in quality systems management

Leading the management of Quality System execution, including Deviation, CAPA, Change Control, Complaints, as applicable

Ensuring timely and accurate reporting via Quality Review Boards/Management Review on the performance of AbCellera’s QMS, along with associated required improvements

Experience in GMP manufacturing, and testing requirements for biologics, including aseptic technique/operations, environmental monitoring programs, and media simulation studies

Within this project, collaborating closely with the project team and extended team members through effective communication and project management.

Responsible for controlled document management in the Tru Enovia application. This includes authoring/revising and routing the following document types:

Strong consideration will be given to candidates with advanced knowledge of Microsoft Office suite of programs and technical writing experience.

Knowledge of Good Manufacturing Practices and Good Documentation Practices

Previous experience in a Quality Assurance or Laboratory setting

Prior experience within a GMP environment