Senior Quality Assurance Advisor Jobs

Experience with managing and conducting supplier qualification activities, internal and external audits

Understanding of quality control methods, method qualification and method validation activities.

Oversee and/or execute internal and external audit programs ensuring compliance with regulatory requirements and industry standards

Oversee, develop and/or execute BlueRocks Supplier Qualification program.

Experience in Cell & Gene Therapy or Sterile Large Molecule Biologics highly preferred

Seeking a highly adaptable and skilled problem solver with a proactive attitude comfortable with ambiguity

Oversee supplier management system and supports the raw material qualification program

Provide regular updates to senior management and corporate

Directly supervise two (2) Department Managers and supervises activities performed by QA teams

Evaluate and assess change controls to determine applicable requirements and assist in determining regulatory reporting classification and requirements

Practice high level of facilitations skills to reach consensus and works toward solutions

Manage the Risk Assessment System process

Assist with customer escalations and complex claim management as needed

Strong computer skills including working knowledge of Microsoft Office Suite (MS Word, MS Excel, Outlook) and various Claims systems

Collaborates with Claims team to understand opportunities for improvement and leverage resources to build exceptional file handling practices and capabilities

Post-secondary education (university degree or college) completed in a related field

Expertise and knowledge in Surety, New Home warranty, Systems Warranty and Professional Liability would be an asset

Well-developed written and verbal communication skills sufficient to present results, analysis and materials involving detailed descriptions and explanations

Extensive knowledge of Quality System regulatory requirements, including 21 CFR 820, 21 CFR 210 and 211

Minimum 10 years’ experience combined in quality unit and manufacturing in the biotech regulated industry or equivalent

GMP experience in biotechnology, pharmaceutical, or life science field is required

Experience building teams and managing people leaders

Establish and maintain Quality systems required for new product introduction, technology transfer, manufacture and distribution of new and regulated STEMCELL products

Leads QA evaluations, and creation and execution of quality strategic planning to ensure compliance and business needs

Solid experience of use case generation, automated & manual testing, and bug lifecycle management.

Demonstrated experience with case management and workflow-based systems

Proven experience of functional testing in Microsoft Dynamics 365 Customer Engagement (CE) and Finance & Operation (F&O)

Strong knowledge and experience of:

Use case generation, automated and manual testing, and bug lifecycle management

Bug tracking and test case management tools (JIRA, Azure TFS)

7 years of related experience in Quality Management and/or Construction Management is preferred.

Strong analytical, data management skills.

Manage the internal management of Change Process (MOC) of the team.

High level of customer service and relationship building capabilities

Effective written and verbal communication skills with the ability to effectively get along with personal at all levels of the organization.

Lead the activities of the Quality Operational Team comprised of 2 Quality Assessors and 2 Quality Analysts.

Solid background in creating QA strategies, testing procedures and defect management

Defect management for areas owned

Minimum 8 to 10 years’ hands-on experience testing Web Applications (.NET)

Strong experience using Microsoft DevOps Test Plans

Strong experience writing SQL queries

Experience testing Business Intelligence reports/dashboards (e.g. Power BI) is an asset

Provide QA leadership during investigations involving incident management

Proactively seek resolution to issues according to Management Information reports and resolve issues within appropriate timelines and ensure vendor accountability

Solid understanding of Quality principles and Management Systems

Assist Senior Manager, Quality Assurance as required, with special projects relating to product development, quality assurance and other initiatives

University education or equivalent in Science, Chemical Science, Engineering, Pharmacy or equivalent subject area

Minimum 4 years’ related work experience in retail or manufacturing environment

3+ years of hands-on experience required into ETL Testing tools .

Practical experience in testing large-scale datasets using SQL.

Analyzing the Technical and Functional Business Requirements.

File to file, file to DB and DB to DB validation experience.

Exposure in Banking & Finance domain

Creating test cases for ETL mappings and design documents for production support.

Any other combination of relevant experience could be considered

Excellent prioritization skills and ability to work on several files at the same time

Knowledge of Word, Excel and PowerPoint

Experience with audit mandates related to regulatory financial information, an asset

Lead the project and coordinate the preparation of work in line with OSFI’s assurance expectations over capital, leverage and liquidity returns

Help establish the schedule of deliverables, ensure regular and thorough follow-ups on the progress of objectives and contribute to their achievement

Deep knowledge and technical proficiency gained through extensive education and business experience.

Provides guidance on reviewing, evaluating and driving requirements for testability to ensure review processes are adhered to.

Leads initiatives. Able to coordinate resources and manage problems to resolution when necessary.

Manages and leads the development and implementation of complete test strategies.

Reviews, evaluates, and derives requirements for testability.

Designs, develops, executes, and maintains testing strategies and plans to ensure stability and efficiency, enabling a seamless customer experience.

Experience in MS Office, Excel, and database management

Business / Project management skills (e.g. schedule, cost, resource planning, etc.)

Collaborate with multidisciplinary engineering and project management teams to mitigate the risk associated with quality system implementation and safety in design

Familiarity, understanding, knowledge, and previous experience of the following:

Free access to our Aspire Academy for continuing professional education

Medical and dental benefits once qualified

Experience in MS Office, Excel, and database management

Business / Project management skills (e.g. schedule, cost, resource planning, etc.)

Collaborate with multidisciplinary engineering and project management teams to mitigate the risk associated with quality system implementation and safety in design

Familiarity, understanding, knowledge, and previous experience of the following:

Free access to our Aspire Academy for continuing professional education

Medical and dental benefits once qualified

Experience in MS Office, Excel, and database management

Business / Project management skills (e.g. schedule, cost, resource planning, etc.)

Collaborate with multidisciplinary engineering and project management teams to mitigate the risk associated with quality system implementation and safety in design

Familiarity, understanding, knowledge, and previous experience of the following:

Free access to our Aspire Academy for continuing professional education

Medical and dental benefits once qualified

Experience in MS Office, Excel, and database management

Business / Project management skills (e.g. schedule, cost, resource planning, etc.)

Collaborate with multidisciplinary engineering and project management teams to mitigate the risk associated with quality system implementation and safety in design

Familiarity, understanding, knowledge, and previous experience of the following:

Free access to our Aspire Academy for continuing professional education

Medical and dental benefits once qualified

Experience in MS Office, Excel, and database management

Business / Project management skills (e.g. schedule, cost, resource planning, etc.)

Collaborate with multidisciplinary engineering and project management teams to mitigate the risk associated with quality system implementation and safety in design

Familiarity, understanding, knowledge, and previous experience of the following:

Free access to our Aspire Academy for continuing professional education

Medical and dental benefits once qualified

Superior, demonstrated process and/or quality improvement and change management experience, leading complex, interdisciplinary and cross-program/enterprise initiatives is preferred.

Solid understanding and experience with project management principles and managing projects.

Function as a lead and support the coordination and facilitation of projects using project management fundamentals.

Manage multiple project goals, timelines, milestones, and resources in collaboration with hospital programs, and enabling services.

Educate and lead knowledge translation during implementation of quality improvement initiatives to frontline/enabling services staff.

A Master’s degree specializing in quality and/or patient safety, business administration, public health, or healthcare administration or equivalent experience is preferred.

Experience and Skill Set Requirements

Experience assisting in the analysis and definition of testing scope during an iteration

Experience with all test activities including functional, integration and regression testing of Web application components and reports

Experience reporting test results and coordinating defects through the testing lifecycle of a project

Experience performing database verification using SQL in an Oracle environment

·Experience following a clearly defined test strategy

Excellent project management skills, advanced written and verbal communication skills

Direct fieldwork daily, inform supervisors of the engagement status, and manage staff performance.

Use technology to continually learn, share knowledge with team members, and enhance service delivery.

Learning opportunities to develop new skills and progress your career

Develop and maintain productive working relationships with client personnel and assess clients' satisfaction.

Proactively maintain contact with the client throughout the year.