Quality Control Specialist

Who we are:

Response Biomedical Corp. (Response) has been transforming acute care diagnostic testing with a focus on improving patient outcomes for over 30 years. We are a Canadian-owned company that develops, manufactures and distributes immunoassays around the world. We believe the people we work with, including our partners, healthcare teams, and employees are the cornerstone of our success.

The RAMP platform is a global leader in cardiovascular and acute care testing for the triage and diagnosis of life-threatening diseases directly from whole blood samples. We understand the stresses associated with rapid and accurate diagnosis when every minute counts and we are committed to providing lab-quality results within minutes while reducing the total cost of care.

We are searching for an Quality Control Specialist to join our Quality Control team that is ready for a challenge and looking to make a difference. The successful candidate will be responsible for the 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.

• Performs QC testing of incoming raw material, in-process components and finished products as part of routine QC and batch release activities for RAMP products including complex data analysis in accordance with approved procedures, specifications, and acceptance criteria.
• Performs OOS investigations and generates or supports investigation documentation to support manufacturing troubleshooting, complaint handling, and quality system activities.
• Performs monitoring stability study testing and supports completion of stability study documentation as required.
• Performs validation testing required for analytical method development, method verification, or QC process improvement activities.
• Supports analytical method development and testing activities required to maintain or improve QC methods.
• Reviews QC documents for all QC testing, including testing that requires complex data analysis, to ensure that results are accurate, complete, and meet specifications.
• Continuously reviews Q C data to identify trends, unusual results, or potential issues in established controlled processes and procedures.
• Collaborates with Product Development and Product Support on cross-functional projects related to QC testing, product performance, investigations, or process improvement.
• Edits DCOs and provides technical insights on improvement of QC testing procedures and acceptance criteria.
• Assists in organizing QC activities to meet operational targets, supports inventory counts and assists in resolving discrepancies as required.
• Performs laboratory housekeeping.

• Provides QC testing support and technical input to Manufacturing as required while supporting manufacturing, QA, Product Development, and Product Support by performing testing or providing QC input related to troubleshooting, investigations, and product or process issues.
• Communicates testing status, technical observations, and quality concerns to support alignment between QC and Manufacturing activities.

• Adheres to and enforces compliance with Quality Management System (QMS), GMP, GDP, ISO, and safety regulations, ensuring adherence to Standard Operating Procedures and Work Instructions.
• Ensures accurate and timely completion of regulatory and QC documentation, and reports quality and equipment issues to the QC Manager.
• Supports OOS, NC, CAPA, CCR, VR, and other quality system activities in accordance with QMS requirements including periodic review of QC documents and contributes to improvement of QC documentation quality.
• Supports continuous improvement of GMP, QMS, QC testing procedures, and acceptance criteria.
• Escalates quality…