Quality Control Specialist

Response Biomedical • Vancouver, BC

36d • CA$50,000 - CA$55,000 • Onsite

About The Position

Response Biomedical Corp. is seeking a Quality Control Specialist to join their Quality Control team. This role is responsible for testing incoming raw materials, conducting in-process inspections for manufacturing, and performing analytical testing of components and finished products to ensure quality standards, procedures, legislation, and specifications are met. The specialist will also monitor QC specifications and metrics to identify trends in controlled processes and procedures, with the ultimate goal of improving patient outcomes and saving lives globally.

Requirements

• Post-secondary degree in Chemistry, Biology, Biochemistry, Medical Technology, or related fields.
• Minimum 2 years direct experience working in a regulated laboratory.
• Minimum 1 year experience in QC settings.
• Proficient in Microsoft Office Suite, particularly Word and Excel.
• Experience working with QMS, risk management, and NC/CAPA investigations.
• Strong understanding of QC testing processes, analytical methods, data analysis, and regulated laboratory practices.
• Ability to review QC documentation and testing data, including records requiring complex data analysis.
• Strong problem identification and problem resolution skills.
• Strong technical writing skills; excellent written and verbal communication.
• Demonstrated ability to work as part of an interdisciplinary team and independently in a professional environment.
• Excellent time management skills and ability to multi-task; able to complete tasks with flexibility in responding to changes in direction and priorities.
• Excellent organizational, interpersonal, and communication abilities, ensuring clear collaboration across teams.
• Exhibits personal values that strongly align with the company’s vision, values, and culture, contributing to a positive team environment.
• Authorized to work in Canada.

Nice To Haves

• Occupational First Aid level 1 or higher is an asset.
• Experience in analytical testing or medical device industry is preferred.
• Experience with OOS investigations, stability study testing, validation testing, QC document review, or DCO activities is preferred.
• Experience related to medical devices, protein biochemistry, and immunological methods is an asset.
• Experience in ERP systems for QC data input and management is preferred.
• Knowledge of GMP, GDP, ISO 13485, GLP, MDSAP, Design Control, and worker safety requirements is an asset.

Responsibilities

• 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 concerns, documentation issues, testing risks, or abnormal results as appropriate.
• Follows safety protocols and ensure proper handling of biohazardous materials, chemical reagents, QC samples, and laboratory equipment to maintain a compliant and safe work environment.
• Ensures that QC areas are kept clean and organized and reports safety concerns, equipment issues, and potential risks to the QC Manager or designate.

Benefits

• Salary range of $50,000 to $55,000 annually, depending on experience and qualifications.
• Salary structure aligned with market standards.
• Commitment to a diverse and inclusive workplace.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level