Job Description

Overview
Element Toronto has a current opening for a Quality Specialist III to join our growing team in Mississauga. The Quality Specialist III is responsible to support the QA Manager, Laboratory Managers and Personnel in achieving and maintaining compliance to Element's Quality Systems and Procedures, and GMP regulatory requirements. Duties include performing internal audits, preparation for external client and regulatory audits, facilitating investigations, corrective actions and mentoring technical staff in effective root cause analysis. Additionally, the Quality Specialist III will assist with GMP training for staff and new hires, provide support for instrument/software qualification protocols/reports and prepares trending reports for deviations and investigations.
Responsibilities

• Stay updated on cGMP, ISO 17025, and pharmaceutical lab regulations.
• Collaborate with QA Manager and lab management to improve policies and ensure compliance with current regulations.
• Help prepare GMP training materials.
• Support training of new staff and recommend updates to training matrices.
• Update and qualify quality-critical vendors per company policy and assist in drafting and review of quality agreements with vendors and clients.
• Maintain organized records (training, validations, investigations, CAPAs).
• Ensure documentation accuracy and compliance with SOPs and internal procedures.
• Assist QA Manager with preparation and support with external audits.
• Facilitate and review investigations. Ensure corrective actions are followed and escalate unresolved issues. Perform deviations trending and maintain CAPA system.
• Foster a professional and collaborative environment with lab staff and management

Skills / Qualifications

• Excellent time management and prioritization
• Advanced reading, writing skills
• Strong attention to detail
• Good interpersonal skills
• Ability to articulate how work impacts the larger business
• Ability to provide clear instruction to others while delegating and coaching
• Ability to work in a team environment
• Excellent presentation skills with the ability to communicate complex topics to a variety of audiences
• Ability to write technical reports without guidance and help others in doing so
• Bachelor's degree in chemistry/life sciences
• 10+ years relevant experience
• Role Models the Element Values
• Strong knowledge in regulatory requirements in the pharmaceutical industry. Experience working with regulatory agencies (Health Canada, FDA)

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Company Overview
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 9,000 brilliant minds operating from 270 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
Diversity Statement
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
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Skills Required