Overview
Quality Control Specialist Jobs in Vancouver, BC at Response Biomedical
Full job description
Who we are:
Response Biomedical Corp. has been transforming acute care diagnostic testing, with a central focus on improving patient outcomes and healthcare reform for over 20 years. Response Biomedical fosters a values-based culture, committed to making diversity and inclusion our way of doing business. We believe the people we work with including our partners, medical teams, and employees are the cornerstone of our success.
What we do:
Our RAMP platform is a global leader in diagnostic testing solutions for use in cardiovascular, infectious disease, sepsis, women’s health, arbovirus, and biodefense. We understand the stresses associated with rapid, accurate diagnosis when every minute counts, and are committed to collaborating with the teams that are dedicated to saving lives. We do this by providing lab-quality results within minutes that medical teams can trust, while reducing total cost of care.
Who we are looking for?
We are seeking for a dynamic Quality Control Specialist who is self-motivated and enjoys working in a fast paced environment. This position is responsible for the direct testing of incoming raw materials, completing in process inspections for manufacturing, and the analytical testing of components and finished products to ensure that quality standards and procedures are met and aligned with legislation and required specifications. The Quality Control Specialist is also responsible for monitoring QC specifications and metrics to identify trends in established controlled processes and procedures, for the core purpose of improving patient outcomes and saving lives globally.
Key Responsibilities:
Quality Control
Performs testing of raw materials and independently executes ongoing product testing as part of routine batch release for RAMP products.
Develops, executes, and maintains product stability studies to ensure labeling claims are supported for field products and new development work.
Reviews Quality Control documents to ensure that all products meet specifications.
Continuously reviews Quality Control data to identify trends in established controlled processes and procedures in order to initiate Corrective and Preventative Actions as required.
Generates SOPs, test method documentation, deviation reports, investigation summaries, change control reports, and certificates of analysis.
Assists with analytical method development and performs validation testing as required.
Provides training as required.
Performs laboratory housekeeping.
Manufacturing Support
Provides technical and process direction to Manufacturing.
Performs QVB and in-process inspections of production activities as required and provides training on these as required.
Quality Systems
Ensures compliance with the requirements of working in a regulated environment under the guidelines set by the Company to assure adherence to its internal Quality Management System (QMS) and applicable global requirements.
Ensures adherence to Standard Operating Procedures and Work Instructions and supports CAPAs, VRs, and NCs in accordance with the QMS.
Supports continuous improvement of the Quality Control GMP systems and QMS.
Conducts investigations and root cause analyses (OOSs, NCRs, CCRs) to support manufacturing troubleshooting and/or complaint handling.
Education, Work Experience, Knowledge, and Skills:
Formal Education…
Title: Quality Control Specialist
Company: Response Biomedical
Location: Vancouver, BC
Category:
