Career Openings
Current Positions Available:
SQI Diagnostics is a dynamic, fast-growing company based in Toronto, Canada. We offer competitive salaries, a generous benefits package and a stimulating, challenging and supportive work environment.
What is important to our employees is important to us. SQI Diagnostics considers the health and well being of our employees to be one of our highest priorities. We are pleased to offer a comprehensive benefits package designed to help our employees stay healthy, meet their financial goals and balance the demand of work and personal life. Benefits include:
- Competitive Wages
- Medical and Dental Insurance
- Life and Accidental Death & Dismemberment Insurance
- Long Term Disability Insurance
- Holiday Schedule
- Bereavement Leave
Diversity
At SQI Diagnostics, we embrace a diversity of ideas, contributions and people. We open our minds and align our actions with a variety of backgrounds, talents, lifestyles and points of view from the world around us – it's one of the things that defines our culture and makes us unique.
Employment Opportunities
We are continually looking for great people to add to the SQI team in the following fields:
- Scientists & Technologists to support our growing Assay Development team
- cGMP experienced manufacturing technologists
- Field Service Engineers with experience in fluid robotics and IVD devices
- Microarray Printing Technologists
- Customer Service and Support Technicians
- Director of Sales and Sales Representatives for U.S., Canada and Europe
- Director of Strategic and Tactical Marketing
- Director of Managed Care & Reimbursement
- Autoimmune and Automation Product Manager
- Director of Business Development: diagnostic testing laboratories
- Sales Financing Consultant: lease, reagent rental, cost per test contracts
POSITION:
Software Quality Assurance Manager
ROLE:
The Manager of Software Quality Assurance is responsible for ensuring
that the: (1) design and development of the devices and (2) automated
processes used to manufacture the devices are carried out according to
established procedures and are validated.
Specific Responsibilities:
Product Development
Ensure that platform (software and hardware) development follows design
control procedures (USA 21 CFR part 820.30 subpart C design control) and
other aspects of 820.30 and other regulations pertaining to software and
hardware product development such as risk analysis (ISO 14971). Oversee
and audit the outputs of the process which are incorporated into the
Design History File, including verification and validation reports.
Manufacturing automated processes
Responsibilities include writing and implementing procedures to support
software validation of the automated processes used in manufacturing and
the quality system; creating software validation protocol templates to
be used when performing validations; writing Validation Master Plans and
User Requirements documents for software validation projects; evaluating
software of existing lab or manufacturing equipment and software
applications throughout the company for 21 CFR Part 820 compliance;
working with key individuals from various departments to ensure
compliance of software in use; providing guidance to the various
departments when purchasing software to ensure it is 21 CFR Part 820
compliant.
The individual will execute predefined installation, operational, and
performance qualification protocols and will be responsible for
developing and publishing new protocols as the project environment
dictates. This person will be responsible for reporting deviations,
writing validation reports, memos, amendments, and addenda, providing
technical input to compliance challenges and risk assessments.
Skills:
- Demonstrates the experience and ability to plan systems and
acceptance test strategies and approaches for independent verification
and validation of target application software under test. Must possess
data analysis/management skills.
- Demonstrates the experience and ability to design and develop
detailed test procedure specifications for automated execution of system
test cycles and simulations.
- Develops guidelines and procedures for the use of test
databases and systems testing, and independent verification and
validation methods and technology.
- Designs control procedures, investigation process and
application of quality investigation for root cause analysis and its
impact on products/processes and design
- Highly motivated, conscientious, self-managed team player
- Able to work under minimal little supervision / technical
oversight
- Strong problem solving skills and proven technical competency
- Possesses superior oral and written communications skills in
order to clearly and effectively convey issues, reports, and other
deliverables
- High attention to detail and excellent organizational skills
- Good knowledge of GAMP (Good Automated Manufacturing
Practice), GMP, ISO 13485:2003, ISO 14971:2007, CMDCAS and EU IVD
regulations
- Strong proficiency with Microsoft Office productivity suite
- Other: Bachelors Degree in a scientific discipline or engineering;
certification a plus; minimum of 5 years of direct software validation
experience in the biotech environment; experience with writing SOPs and
Validation Master Plans; hands-on experience writing IQ/OQ/PQ protocols
summary reports; hands-on experience validating software to meet 21 CFR
Part 820 compliances.
POSITION:
Development Associate
OVERVIEW:
The Development Associate assists the Assay Development Scientists in the development of in vitro diagnostic assays on automated microarray platform in the field of human autoimmune diagnostics.
JOB DESCRIPTION
Working under the guidance of development scientists to:
- Conduct experiments during the initial discovery stage of the assay’s development
- Perform verification tasks to confirm specifications of the assay
- Perform tasks to assist in optimizing the assay
- Perform technology transfer from development to manufacturing
- Perform study protocols to validate product performance
- Assist in the development of GMP processes, including manufacturing and QC procedures
- Document development and other GLP activities following design control procedures and other quality management system procedures
- Contribute to establishment of new SOP's within the company
- Maintain laboratory notebooks, prepare analysis summaries, assist in developing study protocols and statistical analyses
- Perform other related duties as assigned.
QUALIFICATIONS:
- BSc or MSc degree, preferably in a biological field, with at least 2 years of laboratory experience
- Experience in the pharmaceutical and/or diagnostic or related industry is preferred
- Must be a self-starter, and when trained, will require little supervision.
POSITION:
Scientist, Assay Development
OVERVIEW:
Assay Development Scientists lead projects to develop in vitro diagnostic assays on automated microarray platform in the field of human autoimmune diagnostics.
JOB DESCRIPTION
- Responsible for the development of assay disease diagnostic products of SQI diagnostics
- Lead the development of surface coatings and their manufacture as well as the development, from Discovery Phase through completion, of microarray components and assays, as determined by the senior management team with input from the various scientific teams at SQI.
- Develop and optimize the assays on SQI’s micro-array platform through assay design including antigen capture method, blocking method, reagent selection, predicate method selection, calibrator/calibration development, and assay conditions to achieve high level of assay performance.
- Conducting technology transfer to manufacturing
- Conducting validating studies leading to regulatory submissions
- Be required to provide scientific and technical leadership to junior staff in Assay development and maintain laboratory records and ensure compliance to SQI quality processes
- Conduct numerous experiments in developing the initial discovery stage products
- Perform verification tasks to identify aspects of development
- Perform optimization of the product
- Development of GMP processes, including manufacturing and QC procedures
- Document design control and other GLP activities following company QMS
- Contribute to establishment of new SOP’s within the company
- Prepare laboratory notebooks, summaries, protocols, and statistical analyses
QUALIFICATIONS:
- PhD in a biological field, with at least 2 years of diagnostic development and laboratory experience
- Experience in the pharmaceutical and/or diagnostic or related industry
- Must be a self-starter, multitask oriented
If you have any interest in any one of these opportunities, send your resumé and cover letter to resumes@sqidiagnostics.com for our Human Resources department to review. Please clearly indicate the opportunity of interest in the subject line.
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