Quality Assurance New Product Specialist Jobs in British Columbia

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

Bachelor's degree in a related field, with a minimum of six years of experience within a regulated environment

GMP experience in biotechnology, pharmaceutical or life science field is a must

Thorough understanding of regulatory, corporate, and customer requirements

Ability to prioritize, manage, and coordinate tasks in a dynamic environment

Review, verify and process of QMS records to ensure compliance to QMS standards such as ISO 9001/13485/relevant GMPs, and established procedures

Intermediate skill level with software applications such as Word, Excel, PowerPoint, SharePoint, and Project, and ERP/SAP

Coordinating quality interactions with internal and external stakeholders to ensure accuracy of documentation and efficiency of product release

Performing batch history file review and ERP transactions related to product release

Providing technical support to all staff as related to quality practices

Participate in projects for continuous improvement initiatives within the QA department and corporately

Revise and create standard operating procedures (SOPs)