QA Specialist
2 weeks ago
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
The opportunity
The QA Specialist plays a critical role in providing independent and comprehensive Commercial Quality support within the affiliate. This includes overseeing a wide range of quality system requirements associated with pharmaceutical products, medical devices, combination products, biologics, and cosmetics.
In this position, you will be responsible for various areas of support, such as Storage and Distribution, ensuring the execution of potential quality events and product shortage management. You will also be involved in Supplier Controls, conducting Product Quality Reviews, implementing Risk Management strategies, overseeing Agency inspections and internal audits, managing CAPA processes, and ensuring compliance with overall Quality Manual requirements.
Your primary objective will be to ensure that all product, process, and system-related quality activities within the affiliate, from the receipt of final product through distribution, are aligned with Corporate, governmental, and local regulations and requirements. By diligently adhering to these standards, you will guarantee the highest level of quality and compliance in all aspects of our business operations. As the QA Specialist, you will utilize your expertise in quality assurance to identify and address any potential gaps or areas for improvement. By conducting thorough assessments and implementing robust quality control measures, you will contribute to the continuous enhancement of our quality management systems. Collaboration with cross-functional teams will be essential in this role, as you work closely with various stakeholders to ensure a comprehensive approach to quality assurance. Through effective communication and collaboration, you will foster a culture of quality excellence and support the overall success of the affiliate. Join us in this pivotal role, and together, we will uphold the highest standards of quality, compliance, and customer satisfaction, making a significant impact on the success of our organizationResponsibilities
- Maintain the Documentation Management System (eDMS) as the System Administrator for the Affiliate and support the JAPAC region as required.
- Act as System Administrator for the Quality eLearning Management System (eLMS)
- Ensure training curriculums are established and maintained within eLMS and regularly reviewed with cross-functional leaders.
- Integration of local quality regulations for drugs, biologics, devices, and/or combination products and cosmetics.
- Design effective quality systems, procedures and/or processes within cross-functional teams to ensure compliance as well as efficiency throughout our quality systems.
- Work on assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements.
- Plan, prepare, review, and approve quality documentation such as change controls, product reviews and other local requirements.
- Support self-inspections, and internal, external and MoH audits as directed by the manager.
- Coordinate and investigate quality events such as deviations, non-conformances and corresponding action plans including decisions.
- Monitor metrics and KPIs to ensure compliance.
- Support the Management Review process for the affiliate
Preferred experience
- Strong computer skills, familiarity with SAP, TrackWise, ComplianceWire and OneVault.
- Excellent computer skills, including Microsoft Office and Visio
- Strong written and oral communication skills
- Full understanding of local GxP requirements including regulations and standards affecting device, biologics, pharmaceutical products and cosmetics.
- General knowledge and understanding of AbbVie MD, pharmaceutical, biologic and cosmetic products and regulations.
- Ability to support projects as a team member as assigned by manager.
- Experience working in both a team setting and independently. Works well with manager guidance to complete tactical objectives while able to manage own time effectively.
- Make decisions in collaboration with management.
- Acts as an owner - use available resources to independently complete assigned tasks.
AbbVie is an equal opportunity employer that supports inclusive, flexible, and accessible working arrangements for all. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation or marital status. If you have any support or access requirements, we encourage you to advise us at the time of application. We are committed to creating an inclusive workplace
Additional Information
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.
#J-18808-Ljbffr-
Computer Specialist
2 weeks ago
Hamilton, Ontario, Canada City of New York Full timeCandidates must be permanent in the title of Computer Specialist (Software) or reachable on the civil service list. JOB DESCRIPTION:The mission of the New York City Police Department is to enhance the quality of life in New York City by working in partnership with the community to enforce the law, preserve peace, protect the people, reduce fear, and maintain...
-
Test Specialist(Test Quality)
2 weeks ago
Hamilton, Ontario, Canada City of New York Full timeCandidates must be permanent in the title of Computer Specialist (Software) or reachable on the civil service list. The mission of the New York City Police Department is to enhance the quality of life in New York City by working in partnership with the community to enforce the law, preserve peace, protect the people, reduce fear, and maintain order. The New...
-
Support Specialist Controlling Software m|w|d
2 weeks ago
Hamilton, Ontario, Canada City of New York Full timeIMPORTANTNOTE:Only those currently serving as a permanent or probable permanent Computer Specialist (Software) will be considered. The NYC Department of Environmental Protection (DEP) enriches the environment and protects public health for all New Yorkers by providing 1.1 billion gallons of high quality drinking water, managing wastewater and stormwater,...
-
Specialist, Quality Assurance
1 week ago
Hamilton, Ontario, Canada Stryker Corporation Full timeJob OverviewThis position is responsible for the ongoing support and maintenance of the Quality Management System, through GMP and QA related activities, acting in compliance to drug, natural health product, medical device, cosmetic and CTO regulations. This individual must serve as a contributing member of the QA team while championing Stryker's Mission and...
-
Quality Assurance Specialist
1 week ago
Hamilton, Ontario, Canada The Fedcap Group Full timePosition Summary:The Quality Assurance Specialist is responsible for ensuring Fedcap Canada's established program and organization quality standards are achieved. Working within a wider team, this position provides a critical business function that monitors all elements of our delivery, challenges status quo and supports continuous improvement...
-
Manufacturing Supervisor I
2 weeks ago
Hamilton, Ontario, Canada Allergan Full timeCompany DescriptionAbbVie's main goal is to discover and deliver innovative medications and solutions to tackle severe health issues today and overcome the medical challenges of tomorrow. The company aims to have a significant impact on people's lives in key therapeutic areas such as immunology, oncology, neuroscience, and eye care, as well as through their...
-
Solution Engineer Director
2 weeks ago
Hamilton, Ontario, Canada City of New York Full timeAPPLICANTS MUST BE PERMANENT IN THE COMPUTER SPECIALIST (SOFTWARE) CIVIL SERVICE TITLE, BE PERMANENT IN A COMPARABLE TITLE ELIGIBLE FOR 6.9 TITLE CHANGE OR BE IMMEDIATELY REACHABLE ON EXAM NO. The Department of Social Services (DSS) is comprised of the administrative units of the New York City Human Resources Administration (HRA) and the Department of...
-
director of solution engineering
2 weeks ago
Hamilton, Ontario, Canada City of New York Full timeAPPLICANTS MUST BE PERMANENT IN THE COMPUTER SPECIALIST (SOFTWARE) CIVIL SERVICE TITLE, BE PERMANENT IN A COMPARABLE TITLE ELIGIBLE FOR 6.1.9 TITLE CHANGE OR BE IMMEDIATELY REACHABLE ON EXAM NO The Department of Social Services (DSS) is comprised of the administrative units of the New York City Human Resources Administration (HRA) and the Department of...
-
Supervisor, Quality Operations
2 weeks ago
Hamilton, Ontario, Canada Allergan Full timeSupervisor, Quality Operations (Biologics) AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care –...
-
Specialist, Quality Assurance
1 week ago
Hamilton, Canada Stryker Corporation Full time**Job Overview** This position is responsible for the ongoing support and maintenance of the Quality Management System, through GMP and QA related activities, acting in compliance to drug, natural health product, medical device, cosmetic and CTO regulations. This individual must serve as a contributing member of the QA team while championing Stryker’s...
-
Quality Assurance Specialist
2 weeks ago
Hamilton, Canada Ontario Ravioli Full timeJob Description: Quality Assurance Specialist - Pasta Manufacturing Company: Ontario Ravioli Location: 121 Brockley Dr., Hamilton **Job Type**: Full-Time/Part Time About Us: Ontario Ravioli takes pride in being a distinguished leader in pasta manufacturing, crafting superior products that bring joy to our customers' tables. We are seeking an accomplished...
-
Quality Assurance Specialist
2 weeks ago
Hamilton, Canada The Fedcap Group Full time**Position Summary**: The Quality Assurance Specialist is responsible for ensuring Fedcap Canada’s established program and organization quality standards are achieved. Working within a wider team, this position provides a critical business function that monitors all elements of our delivery, challenges status quo and supports continuous improvement...
-
Computer Specialist
4 weeks ago
Hamilton, Canada City of New York Full time* Candidates must be permanent in the title of Computer Specialist (Software) or reachable on the civil service list. JOB DESCRIPTION:The mission of the New York City Police Department is to enhance the quality of life in New York City by working in partnership with the community to enforce the law, preserve peace, protect the people, reduce fear, and...
-
Computer Specialist
4 weeks ago
Hamilton, Canada City of New York Full time* Candidates must be permanent in the title of Computer Specialist (Software) or reachable on the civil service list. JOB DESCRIPTION:The mission of the New York City Police Department is to enhance the quality of life in New York City by working in partnership with the community to enforce the law, preserve peace, protect the people, reduce fear, and...
-
Material Supply Specialist
2 weeks ago
Hamilton, Canada Maple Leaf Foods Full time**The Opportunity**: The Material Supply Specialist reports to the Purchasing Leader and will be responsible for ordering and monitoring of supplies to meet production needs. **Snapshot of a Day-in-the-Life**: - Monitor supplies to ensure availability to meet production demands - Work with the Purchasing Leader and designated suppliers to implement cost...
-
Quality Assurance Supervisor
2 months ago
Hamilton, Canada The Fedcap Group Full time**Position Summary**: The Quality Assurance Supervisor is an integral member of the Fedcap Canada team whose role is to oversee and support the organization through Quality Assurance (QA) and Compliance related activities. The Quality Assurance Supervisor works in conjunction with Fedcap Canada’s Director of Support Services to ensure compliance with...
-
Bim Coordinator
2 months ago
Hamilton, Canada Walterfedy Full timeRole At a Glance WalterFedy is seeking a well-rounded, energetic BIM Coordinator/BIM Specialist to work with our integrated team on Revit project initiation, BIM coordination, content and technical development. In this role, you will be working closely with the BIM Manager on various projects, while providing support to our Architecture and Engineering...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Senior Solution Architect
1 month ago
Hamilton, Canada City of Hamilton Full timeSUMMARY OF DUTIES Reporting to the Supervisor, Strategy Architecture & Solution, the Senior Solution Architect provides the coordination of delivery of IT solutions targeted to meet business strategies through the identification, analysis, communication and validation of business requirements, identification and deployment of business solutions and...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Manufacturing Supervisor I
4 weeks ago
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Manufacturing Supervisor I
4 weeks ago
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
-
Senior Operations Supervisor
2 days ago
Hamilton, Canada Allergan Full timeCompany DescriptionAbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services...
