Senior Quality Assurance Specialist Job in Markham for Kuehne + Nagel |

Senior Quality Assurance Specialist

May 11 2021
Industries Goods transportation, Warehousing
Categories Information Technology, QA, Tester, Debug
Markham, ON
We are looking for a talented Senior Quality Assurance Specialist for our 3PL Warehouse in located in Markham.

Your Role

The Senior Quality Assurance Specialist will assume responsibility for the ongoing support and maintenance of the Quality Management System at the local level within the assigned business unit(s). This role will execute branch Quality functions employing knowledge including but not limited to: cGMP's, corporate policies and guidelines, company work instructions, client SOP's, and all the applicable Health Canada regulations associated with the functions performed at the assigned business unit(s) (e.g. narcotic control, controlled drugs and substances, precursors, etc.). The responsible person in charge (RPIC) / ARPIC will assume full responsibility for all transactions involving precursors. The QPIC / AQPIC will assume responsibility for all transactions involving controlled and targeted substances.

Your Responsibilities

• Facilitate implementation and compliance activities in alignment with cGMP's, corporate policies and procedures, client SOP's and applicable regulations across all business and functional units in the country;
• Ensure that existing and future QA requirements are cascaded to and implemented by country business units and operations;
• Actively participate, support, and when required lead audits from existing and prospective clients, as well as regulatory bodies
• Perform internal self-inspections;
• Facilitate development of training strategies;
• Support the development of pro-active strategies as preventive measures against potential future issues with systems or processes;
• Identify and investigate incidents from a quality perspective;
• Complete non conformity and planned deviation reports and oversee the execution of CAPA commitments;
• Support National QA management as required;
• Assist QA Manager with new client / product onboarding / setup preparation;
• Develop SOP's, WI's as required;
• Monitor, identify and investigate incidents from a quality perspective;
• Manage the non-conformity and planned deviation process to oversee the execution of CAPA commitments;
• Oversee the day to day activities of the QA Specialists, monitoring of work quality and productivity as assigned by the QA Manager;
• Other duties as may be assigned

Your Skills and Experiences

Professional experience required:
• 6+ years industry experience in Medical Device/Pharmaceutical industry in QA. RA experienced may be considered
• 2+ years industry experience in Medical Device/Pharmaceutical distribution is preferred
• Meet Health Canada's requirements to perform RPIC and QPIC responsibilities

Knowledge required:
• Knowledge of Quality Management systems and standards (i.e: GMP, ISO 13485, ISO 9001)
• Knowledge of warehouse inventory management systems
• Strong knowledge and understanding of GMP's, GDP's, licensing, Federal and Provincial reg

Education required:

• Bachelor in Sciences (e.g. Pharmacy, Chemistry, Biology, Engineering or a related discipline) is required
• Diploma/Degree/Certificate in Quality Assurance is preferred

Skills required:

• Excellent verbal and written communication, presentation and training skills required. Leadership and managerial skills preferred
• Strong computer skills required, including full proficiency with Microsoft Office Suite
• Strong problem solving, organizational and time management skills required; preferred skills include interpersonal and conflict resolution.

This job is not eligible for international relocation support or work permit sponsorship.

Kuehne+Nagel Canada welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.

Apply now!