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.

What we do:

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 diagnosiswhen every minute counts and we are committed to providing lab-quality results within minutes while reducing the total cost of care.

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Who we are looking for?

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.

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

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

Work Experience

• Minimum 3 year of 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

Must-Have :

• Proficiency with Microsoft Office productivity suite and database applications.
• High level of proficiency in Microsoft Excel skills including plotting and using formulas and regression tools.
  
• Strong technical report writing skills.
• Strong problem identification and problem resolution skills.

• 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.
• Strong personal alignment with the companys vision, values, and culture.
  

Nice to Have :

• Coding experience and familiarity with Microsoft Excels VBA coding and macros.

• Experience with risk management, NC/CAPA investigations, and experience working with QMS.
• Experience 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.

The starting salary for this position ranges from $50,000 to $60,000 annually, depending on the candidate's experience and qualifications. Our salary structure is aligned with market standards and is finalized considering factors such as job-related expertise, skills, education, and experience.

Please note that this position is only available to candidates who are authorized to work in Canada.

*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'recommitted to a diverse and inclusive workplace.We welcomeapplicants withoutregardto 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.