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Quality Control Specialist

1 month ago

Vancouver, Canada Response Biomedical Full time

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_

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 :_
- 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 company’s vision, values, and culture.

Nice to Have:

- Coding experience and familiarity with Microsoft Excel’s 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 bio