CAREERS WITH MICROBIX

Microbix Biosystems is a fast growing biotechnology company based in Mississauga.
Founded in 1988 as a producer of infectious disease antigens, primarily for the diagnostics market, Microbix invests in the virology business to build capacity and develop new products to address emerging market opportunities, while enhancing manufacturing and laboratory capabilities and technologies.
Our emerging products take aim at large market opportunities. With Microbix’ core competencies in the Diagnostics business, including cell culture, molecular biology, and GMP quality system, these new products build on Microbix’ strength.

We are currently hiring for the following positions:

REGULATORY AND COMPLIANCE ASSOCIATE

Reporting to the Director of QA and Compliance, a Regulatory and Compliance Associate will work in the QA and Compliance department to support various activities related to the upkeep of our ISO 9001 and ISO 13485 Quality Management System. Also will participate in various regulatory submissions to EU, FDA and Health Canada. This includes organizing and assembling medical device license applications and regulatory dossiers to EU Notified Body, FDA and Health Canada.

Skills and/or Knowledge Required
• Good knowledge of the European, US, and Canadian guidelines / policies regarding regulatory preparations/ submissions
• Experience with CE Technical File and Design Dossier Requirements
• Organization and time management skills
• Strong computer skills, mainly in the use of Microsoft Office
• Strong written and verbal communication skills and Interpersonal skills
• Commitment to team work
• Detail oriented
• 3-5 years of experience in regulatory affairs in a related field; experience within the medical device industry is preferred
Responsibilities:
• Assist in preparation of regulatory submissions to EU Notified Body, FDA and Health
Canada as required.
• Upgrade, as necessary, the Quality Management System (QMS) to meet regulatory requirements.
• Administer the postmarketing surveillance program. Ensure timely investigations of product complaints. Ensure appropriate identification and disposition of product lots related to product complaints based on complaint findings.
• Track and maintain regulatory correspondence and submissions. Review change control requests and determine regulatory filing requirements.
• Provide regulatory support to internal customers (Research & Development, Quality Control, Operations, Sales & Marketing), as required.
• Ensure the practical and effective risk management program that meets regulatory requirements. Ensure that risks are assessed based on their impact on materials, equipment, products, processes or other planned activities.
• Assist in reviewing batch product records. Provide guidance to manufacturing and quality control operations upon request and coordinate product release in a timely manner.
• Participate in conducting internal audits, encompassing the full scope of site operations. Apply risk-based principles.
• Actively support the QA and Compliance department to maximize efficiencies, performance and productivity.

Application
• Please submit your resume and cover letter at microbix@microbix.com

REGULATORY AND COMPLIANCE ASSOCIATE

Microbix is seeking an experienced QA professional who is committed to ensuring completeness and accuracy in Quality Management System (QMS) processes and documentation. Reporting to the Director of QA and Compliance, a QA Manager will support various activities related to the upkeep of our ISO 9001 and 13485 QMS processes and will support existing products and new product introductions by providing and applying Quality Assurance expertise.

Key Accountabilities
Assist the Director of Quality Assurance and Compliance with the maintenance and implementation of QMS processes:
• Ensure the design control activities are performed in compliance with company procedures and applicable ISO standards. Support new product introductions from a quality perspective. Review and approve documentation associated with the introduction or transfer of a new product from development to routine manufacturing
• Oversee risk management processes as applicable to new and existing products. Manage risk management file for and medical devices
• Provide QMS training and ensure annual refresher training for all employees engaged in routine operations
• Support and enhance performance by analyzing and assessing quality control and quality assurance data by identifying patterns and areas for improvements based on QA data over time and utilizes these reports to improve processes and performance
• Development of a formal reporting system to communicate and track results of identified patterns and trends such as dashboards and other metrics
• Assess customer requirements and commitments by reviewing quality agreements or other contracts and ensuring customer requirements are included in the company QMS
• Oversee supplier management program. Ensure that supplier qualification and performance evaluation is according to their criticality assessment and associated risks
• Perform other duties as assigned by the Director of Quality Assurance and Compliance

Experience skills
• Thorough knowledge of and the practical application of ISO 13485:2016, ISO 14971:2012 and FDA 21 CFR Part 820
• Ability to multi-task with ability to be organized. Strong time management skills and attention to detail
• Ability to work in a fast-paced environment with shifting changes in prioritization based on regulatory and business needs
• Good Working knowledge of risk management methods, techniques and analysis
• Strong interpersonal and communication skills. Excellent written and oral communication skills
• Proficient at supporting effective interactions between team members and among cross-functional teams.
• Proficient experience with MS Office suite (Word, Excel, Outlook)

Education
• 5-10 years of experience in Quality Assurance management role in the medical device or pharmaceutical industries with a record of increasing responsibilities.
• Bachelor’s degree in Science, or related field

Application
• Please submit your resume and cover letter at microbix@microbix.com

QUALITY CONTROL TECHNICIAN

With exciting new products coming online the company is seeking a quality control technician to work in our state of the art quality control lab.

Primary Function:
•The Quality Control Technician performs a variety of QC testing, from raw materials to finished antigen products, according to SOPs;
•Maintains laboratory, equipment and materials required for the operation of the Quality Control laboratory.

Education:
•Undergraduate degree in Biochemistry or Biological Sciences (Molecular biology, Cell Biology, Immunology, Microbiology or Virology) or equivalent

Experience / Knowledge:
•Knowledge and experience in protein, immunoassay, PCR & microbial assay.
•Knowledge and experience in tissue culture handling and cell base assays
•Track record in quality control and development lab in a GLP/GMP environment..
•Familiar with EPR software.

Responsibilities / Skills / Competencies:
•Performs antigen quality control product testing as outlined in the standard operation procedures and approved work instructions;
•Performs raw material inspection, reagent preparation and sterility testing according to SOPs;
•Performs quality control testing on stability and validation samples and maintains an accurate inventory log of the samples;
•Adheres to GMP and safety procedures;
•Completes documentation such as testing records, reports and non-conformance documents factually, accurately and on a timely basis;
•Effectively and reliably identifies and reports any non-conformances;
•Be able to multi-task and prioritize job functions. & works in a systematic and structured fashion and accomplishes tasks within expected periods of time;
•Communicates well with colleagues to facilitate information exchange and coordinate equipment usage, material releasing, sample transferring and testing;
•Be effective and productive in a group / team environment. Actively participates in summary meetings. Provide continual and effective feedback with manager / subordinates

Application
• Please submit your resume and cover letter at microbix@microbix.com