Quality Systems Associate 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

Have a minimum of 7 years professional animation experience.

Reliable internet service to work remotely.

Production experience in a professional animation setting.

Ensure all animations contribute to the direction of the game in both the experience and the story being told.

Degree in Fine Arts or Computer Animation.

Work with the Animation Director and Leads to deliver quality animation that meets outlined expectations.

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.

1 -2 years of experience within a Pharmaceutical , Biotech or equivalent business

Sound knowledge of Canadian GMP/GDP

Experience associating with Health Canada through inspections or communications

Knowledge of Pharmaceutical operations regarding manufacturing process and regulations.

Timely review of batch documents and release of commercial products

Support product launches and site transfers ensuring all documents and QA systems are in place for release.

Work with software engineers, product managers, and other QA testers in an Agile team environment

Experience coding in Java AND/OR mobile languages

Fresh graduate or relevant work experience, including software development and/or software test automation

Strong verbal and written communication skills

Knowledge of Java, Python, or other object-oriented programming language

Knowledge of Atlassian products like Jira, Greenhopper, and Clover is an advantage

Ensure recipes and ingredients are prepared according to the proper procedures and record the data;

Communicate with associates the weekly guidelines regarding the critical ingredients and operations notes;

Conduct randomized sample audits of recipe bags and record the data

Inspect the ingredients before portioning and coach employees at the start

Provide training to employees on Goodfood work methods, Good Hygiene practices, and other relevant topics;

Conduct the onboarding presentation to new employees;

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.

Excellent data quality and management skills

Excellent organizational and time management skills

Manage data entry timelines according to sponsor requirements

Transcribe patient research data from source documents into sponsor data management systems (e.g., eCRFs)

Translate data quality results into clear business impact statements to help understanding and adoption of data management practices.

Experience with various electronic data entry systems

Excellent data quality and management skills

Excellent organizational and time management skills

Manage data entry timelines according to sponsor requirements

Transcribe patient research data from source documents into sponsor data management systems (e.g., eCRFs)

Translate data quality results into clear business impact statements to help understanding and adoption of data management practices.

Experience with various electronic data entry systems

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.

Collaborate with product managers, designers, developers and other team members to identify and implement test plans

Experience with scripting/automation frameworks such as Selenium or Cypress

Be a scrum team member on an agile software development team

Focus on incorporating test strategies throughout the development process

Determine where and how Automation can be incorporated

Work with the developers to implement automated tests

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

Assist to document the quality instructions and quality reports based on customer/product/material requirement

Knowledge of quality metrics ,ISO and IPC standards and processes

Basic quality tools (7 tools, SPC, etc) Good analytical and problem solving skills.

Handle the quality incidents in production through manufacturing systems.(Rework/EC(Engineering Change)/RMA((Returned Material Authorization)/)/OBA(Out of Box Audit) /Training)

Supports audits to help maintain compliance, particularly for the validation on corrective actions (system/process/product)

Provide production line workflow support (Shop Floor Control System routine activities, Purge process, Trial run,etc.)

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