As the Microbiology Technician at OmniaBio, you are a motivated individual in the field of Microbiology for Good Manufacturing Practices (GMP) manufacturing. Microbiology EM team is responsible for all aspect of quality for environmental monitoring and APS sampling for the organization. The Microbiology Technician will be required to work across the entire range of activities, including but not limited to maintaining the environmental conditions in our clean rooms by performing environmental monitoring, testing, sample management and execution of method suitability as well as supporting APS process in visual inspections and media growth promotion. You will demonstrate flexibility within the quality and larger organization, flowing to work priorities as required. Environmental monitoring (EM) is an enabling function and as such this role will support production and facility needs to ensure product supply to patients. You will ensure the high-quality delivery of contract services.

Responsibilities:

• Deliver quality control microbiology related services as contracted, to various cell and viral product centered clients.

• Collaborate with Production, Manufacturing Science and Technology (MSAT), and Facilities in the preparation of environmental monitoring strategy and execution.

• Execute the EM schedule.

• Adhere to the documentation (QMS) program, including SOPs, logbooks and associated forms.

• Maintain the sample management program, including sample identification, storage and retention.

• Maintain equipment log-books/records and a Preventative Maintenance (PM) schedule for applicable equipment.

• Update SOPs with approved information from deviations, change controls, CAPAs and continious improvement.

• Perform aseptic gowning qualification and support the sampling of gown qualifications.

• Provide in-suite and on the floor support for OmniaBio’s manufacturing teams, ensuring a compliant and fast to patient mindset. Plan and execute EM sampling for all in-suite activities. Collaborate with production, QC and Facility peers, to co-create solutions to remediate compliance and quality issues.

• Perform room status update and ensure all EM documentation is complete and available for approval.

• Participate in internal audits as required.

• Participate in Client audits and Health Authority audits as required.

• Participante in deviations, corrective and preventative actions (CAPA), Change Controls, etc.

• Ensure GMP is embedded in all manufacturing related tasks.

• Engage and support the OmniaBio Operating Model (OBOM) continuous improvement philosophy.

• Continuously grow and adapt in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.

• Represent OmniaBio and promote its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.

Requirements:

• Minimum 2-year college program with relevant or related experience
• Up to and including 1 year practical and related experience and/or 6 months on-the-job training in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
• Ability to meet Visual Exam Requirements

Desired Characteristics:

• Independent, detail-oriented, self-starter with the ability to multitask and succeed in a team environment.
• Demonstrate initiative and the ability to deliver high quality outcomes.

OmniaBio is a developing organization and represents a fluid working environment. Flexibility and adaptability are essential, and duties will be influenced by the needs of the organization.

Applicants must be legally eligible to work in Canada.

An applicant’s compensation package is finalized once the interview process is concluded and accounts for the nature of the role as well as the experience, competencies (job knowledge, skills and abilities) of the applicant and internal equity.

OmniaBio is committed to accessibility, diversity, and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process, providing the applicant has met the bona fide requirements for the open position. Applicants should make their requirements known once contacted to schedule an interview, or when the job offer has been made.