Career Level Staff
Experience 2 Years
Industry Business/ Management
Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
Based within the Alere Toxicology part of the business and reporting to the Quality Systems Manager, the Quality Specialist will be involved in the implementation, maintenance and continuous improvement of the Quality Management System in accordance with, ISO 17025, Forensic Science Regulator and Abbott Quality and Regulatory requirements.
- Support activities to ensure the quality management systems are maintained in line with all standard and regulatory requirements.
- Support non-conformance management practices within the organization (QI/CAPA).
- Support the internal and external audit programs.
- Support critical QMS activities including document control, change management, risk management etc.
- Recording and analysis of metrics and trends for key quality processes
- Draft and publish policies and SOPs tailored to the business.
- Support training of members of staff in all aspects of quality as required
- Support the wider QA/RA team in routine activities.
- Responsible for exhibiting professional behaviour with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Perform other duties & projects as assigned.
BASIC QUALIFICATIONS | EDUCATION:
Bachelor’s Degree in related field
Minimum three years’ experience in Laboratory Quality Assurance, toxicology or forensic toxicology.
Understanding of ISO 17025 or suitable equivalent ISO standards
Ability to effectively and constructively communicate across departmental disciplines while pursuing project goals
Experience in writing Standard Operating Procedures and upgrading Quality Systems.
Five years’ experience in Quality Assurance within an accredited laboratory.
Experience of toxicology methods
Designing & delivering training
Strong communication and leadership skills
Able to drive actions to completion across multiple teams
Demonstrate organizational skills with a focus on detailed work
Ability to initiate and manage multiple tasks in a fast-paced environment
Must be able to work as part of a team, meet deadlines & take instruction from multiple persons