Response Biomedical Hiring for Quality Control Specialist at Vancouver, BC Full Time

Who we are:
Response Biomedical Corp. has been transforming acute care diagnostic testing, with the 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 a motivated, dynamic, solutions-focused, and creative individual to join our Quality Control team. The Quality Control Specialist is responsible for the direct inspection/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 accordingly to ensure that defective materials are prevented from entering the supply chain.

Key Responsibilities:
Quality Control

Performs inspections 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.

Education, Work Experience, Knowledge, and Skills:
Formal Education

Post Secondary Education or Degree in Chemistry, Biology, Medical Technology, or Related Science.

Work Experience

Minimum 3 years direct experience working in a regulated laboratory; experience in analytical testing/ medical device industry is preferred.

Familiar with quality management systems, ISO, FDA regulations, guidelines, and associated standards.

Experience in health care, medical device, or similar regulated industry

Skills & Knowledge

High level of proficiency with Microsoft Office productivity suite and database applications.

Strong technical writing skills; excellent written and verbal communication.

Strong problem identification and problem resolution skills. Experience with risk management, NC/CAPA investigations, and experience working with QMS

Knowledge of requirements working in a regulated environment under the guidelines set by the Company to assure compliance with the Medical Device Single Audit (MDSAP) regulations, ISO13485, Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), Design Control and Workers Safety.

Experience related to medical devices, protein biochemistry, and immunological methods.

Excellent time management skills and ability to multi-task; able to complete tasks with flexibility in responding to changes in direction/priorities.

Demonstrated ability to work as part of an interdisciplinary team and independently in a professional environment.

• We regret that relocation will not be provided.
• While we appreciate the interest of all applicants, only those candidates selected for interview will be contacted.

We’re committed to a diverse and inclusive workplace. We welcome applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. All employment decisions are based on business needs, job requirements and individual qualifications.