Raw Materials Lead, Quality Control
2 weeks ago
OmniaBio Inc. is a subsidiary of Toronto-based CCRM ( ccrm.ca ), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing organization (CDMO) dedicated to cell and gene therapies and is expected to be the largest facility of its kind in Canada.
Based at McMaster Innovation Park in Hamilton, Ontario, OmniaBio will anchor a biomanufacturing centre of excellence and open in three phases between 2024 and 2026. OmniaBio has built a substantial team and continues to grow to prepare for this expansion. Benefitting from CCRM’s existing expertise and business practices, OmniaBio currently has established process and analytical development teams and contract manufacturing capabilities. OmniaBio is built upon leadership in induced pluripotent stem cells (iPSCs), immunotherapy and lentiviral vectors (LVVs). The vision is to provide focused support for clients with late clinical-stage manufacturing and commercial supply needs, in addition to early-stage development and first in-human clinical trial material services. Please visit us at omniabio.com to learn more.
Position Summary:
As Raw Materials Lead, Quality Control, at OmniaBio, you are an experienced leader in the fields of quality control (QC) for Good Manufacturing Practices (GMP) manufacturing. The QC team is responsible for all aspects of QC for the organization, and the Raw Materials Lead, Quality Control, will be required to work across the entire range of activities, including, but not limited to, materials sampling and testing, sample management, data review and supplier audits. You will demonstrate flexibility within the Quality team and larger organization, adjusting work priorities, as required. You will provide technical expertise and will be an active contributor to client audits, communicating to customers and management. You will ensure the high-quality delivery of contract services.
Responsibilities:
- Delivers QC-related services as contracted, to various cell and viral product-centred clients.
- Oversees the materials specification program.
- Oversees the release of incoming materials for manufacturing.
- Oversees/performs the sampling and testing of incoming materials, ensuring strict adherence to regulation.
- Oversees the materials sample management program, including sample identification, storage and retention.
- Reviews completed records to ensure compliance to GMP, working with colleagues on the Production and Manufacturing Science and Technology teams to remedy non-compliance and adherence to Good Documentation Practices.
- Manages the out of specification (OOS) and retest program as it relates to incoming materials, ensuring strict adherence to regulation(s).
- Ensures QC resources are made available to support client project requirements.
- Ensures QC team members have the resources and training required to fulfill their duties.
- Builds and manages QC systems, as required.
- Oversees the QC documentation program, specifically the quality management system, including standard operating procedures, logbooks and associated forms.
- Administers the documentation and training programs to the QC function.
- Collaborates with the Engineering & Facilities team to ensure that facilities are available for materials sampling.
- Manages third-party testing by our approved partners and takes part in the qualification processes of third-party laboratories, as needed.
- Participates in internal audits and/or supplier audits, as required.
- Participates in client and health authority audits, as required.
- Prepares, reviews and manages deviations, corrective and preventative actions, change controls, etc.
- Ensures GMP is embedded in all manufacturing-related tasks.
- Engages and supports the OmniaBio Operating Model continuous improvement philosophy.
- Represents OmniaBio and promotes its mission and capabilities to the cell and gene therapy field through participation at conferences, symposia, other venues and customer visits.
- Continuously grows and adapts in a fast-moving field to keep yourself and the organization at the forefront of the cell and gene therapy and regenerative medicine fields.
Requirements:
- Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, biochemistry, chemistry, etc.).
- 6-8 years of experience in a cell therapy/viral quality department supporting GMP production, or similar, within the pharmaceutical, medical technologies, biologics, or similar industries.
- Experience working for a CDMO, third-party testing facility or a biotechnology company performing similar activities.
- Strong understanding of cell manufacture processes and technologies.
- Excellent understanding of Health Canada/U.S. Food and Drug Administration GMP regulations and quality assurance principles.
Desired Characteristics:
- Sound knowledge of applicable regulatory frameworks and requirements for cell and gene therapy and regenerative medicine, such as GMP, ISO, or medical device development.
- Independent, detail-oriented self-starter with excellent analytical skills and the ability to multitask and lead in a team environment.
- Experience establishing customer-facing organizations and service models.
- Demonstrated 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.
-
Quality Control Associate
2 days ago
Pickering, Ontario, Durham region, Canada Nanz Pharma Full timeJob Description: As a Quality Control Associate, you will play a crucial role in ensuring that our products meet the established quality standards before they are released to customers. You will work closely with the Quality Control team to perform various testing procedures and inspections throughout the production process. Your primary responsibilities...
-
Quality Control Material Coordinator
4 weeks ago
Ontario, Canada United E&C Inc. Full timeAt United we are a team of engineers, builders, planners and thinkers that design and build today’s infrastructure, for tomorrow. We come to work every day committed to drive growth and deliver projects that matter for our clients, ourselves, and our communities. Through our work in the nuclear, conventional generation, renewable and power delivery...
-
Contract Quality control technician
3 weeks ago
Ontario, Canada Link Personnel Full timeLink Personnel has been instructed by our client, a leading medical device manufacturer, to hire a Quality Control Technician on a 23 month contract. This is a role well suited to a Technician, looking for the next step in their career with a move into Quality, and offer the possibility of permanency thereafter. Bonus, Parking, Subsidised canteen, Flexible...
-
Quality Assurance Manager
2 weeks ago
Ontario, Canada EightSix Network Inc Full timeThe Burke Group: Human Resources Specialists The Quality Manager is responsible for oversight and compliance with quality requirements in the areas of food safety programs, raw material, in-process quality control, finished product evaluation, internal audits, GMPs, sanitation, pest control, and all other related quality matters. The role requires someone...
-
Quality Control Planner
4 weeks ago
Ontario, Canada Lassonde Full timeReporting to the Maintenance Manager, the Maintenance Planner will provide support to the maintenance department and ensure that all preventative maintenance programs, projects, and day to day activities are planned, scheduled, and coordinated as required to optimize production runs and minimize downtime. This position will be accountable for maintenance...
-
Microbiologist II, Quality Control
7 days ago
Ontario, Canada OmniaBio Inc Full timeReports to: Microbiology Supervisor,Quality Control About OmniaBio: OmniaBio Inc. is a subsidiary of Toronto-based CCRM ( ccrm.ca ), a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. OmniaBio’s facility will be Canada’s first commercial-scale contract development and manufacturing...
-
Team Lead, Accounts Receivable
1 day ago
Ontario, Canada Circular Materials Full time**OVERVIEW**: Reporting to the Director, Financial Operations, the Accounts Receivable Team Lead is responsible for overseeing the accounts receivable team, ensuring accurate financial transactions, reconciliations, and collaborating with other departments to enhance efficiency. This position also includes providing guidance and generating insights to...
-
Quality Assurance Supervisor
4 weeks ago
Ontario, Canada Highbury Canco Corporation Full timeLocated in Leamington, Ontario, Highbury Canco is an industry leader in food and beverage manufacturing and third-party logistics. Recognizing that our employees are fundamental to our success, we strive to provide a rewarding work environment. We offer competitive wages, comprehensive benefits, retirement plan contributions, and ample training and growth...
-
Controls & Data Quality Management Lead
3 weeks ago
Ontario, Canada Logic Executive Search & Workplace Solutions Full timeThe Municipality has a population of 40,000 and is one of the fastest-growing communities in Southern Ontario. Lakeshore’s affordable lakefront community enjoys over 35 km of waterfront, low taxes, high quality of life and abundant recreational opportunities with many family-friendly parks, recreation programs, a multi-use recreation centre, the Atlas...
-
Takwata Builders-Quality Control Technician
7 days ago
Ontario, Canada Cochraneontario Full timeTakwata Builders-Quality Control Technician Position: Quality Control Technician Job Type: Seasonal / Full-Time / Camp Pay Range: To be determined. Who are we? Takwata Builders LP is a wholly owned Taykwa Tagamou Nation (TTN) business specializing in civil earthworks projects. TTN is a Cree First Nation located in Northern Ontario in the Cochrane...
-
VIE - Process Engineer (KP) - H/F
2 weeks ago
Ontario, Canada Saint Gobain Full timeReporting to the Plant manager, the Process VIE will be responsible for running projects improving process controls in our Vinyl siding plant. The role will also support day-to-day production as well as lead problem solving activities to address production issues, interacting with all supporting departments in the plant. Additionally, the role will support...
-
DZ Delivery Driver
6 days ago
Ontario, Canada Big Country Raw Full timeWe wish to thank all applicants for their interest, however only those applicants selected for an interview will be contacted. The Driver is responsible for establishing and maintaining good relations with customers by providing courteous, efficient, and professional delivery service in a safe and timely manner. Their primary goal is to work efficiently...
-
Lead, Quality
4 weeks ago
Ontario, Canada Ontario Health Full timeWant to make a difference in your career? Consider this opportunity! Ontario Health is looking for a Lead to join the Quality division of the Clinical Institutes and Quality Programs portfolio. - Reporting to the Manager, the Lead will collaborate with fellow colleagues in the program and across Ontario Health, external clinical experts, patients,...
-
Takwata Builders-Quality Control Technician
7 days ago
Northeastern Ontario, Canada Cochraneontario Full timeTakwata Builders-Quality Control TechnicianPosition: Quality Control TechnicianJob Type: Seasonal / Full-Time / CampPay Range: To be determined.Who are we?Takwata Builders LP is a wholly owned Taykwa Tagamou Nation (TTN) business specializing in civil earthworks projects.TTN is a Cree First Nation located in Northern Ontario in the Cochrane District along...
-
Takwata Builders-Quality Control Technician
6 days ago
Northeastern Ontario, Canada Cochraneontario Full timeTakwata Builders-Quality Control TechnicianPosition: Quality Control TechnicianJob Type: Seasonal / Full-Time / CampPay Range: To be determined.Who are we?Takwata Builders LP is a wholly owned Taykwa Tagamou Nation (TTN) business specializing in civil earthworks projects.TTN is a Cree First Nation located in Northern Ontario in the Cochrane District along...
-
Takwata Builders-Quality Control Technician
6 days ago
Northeastern Ontario, Canada Cochraneontario Full timeTakwata Builders-Quality Control TechnicianPosition: Quality Control TechnicianJob Type: Seasonal / Full-Time / CampPay Range: To be determined.Who are we?Takwata Builders LP is a wholly owned Taykwa Tagamou Nation (TTN) business specializing in civil earthworks projects.TTN is a Cree First Nation located in Northern Ontario in the Cochrane District along...
-
Takwata Builders-Quality Control Technician
6 days ago
Northeastern Ontario, Canada Cochraneontario Full timeTakwata Builders-Quality Control TechnicianPosition: Quality Control TechnicianJob Type: Seasonal / Full-Time / CampPay Range: To be determined.Who are we?Takwata Builders LP is a wholly owned Taykwa Tagamou Nation (TTN) business specializing in civil earthworks projects.TTN is a Cree First Nation located in Northern Ontario in the Cochrane District along...
-
VIE - Process Engineer (KP) - H/F
2 weeks ago
Ontario, Canada Saint-Gobain Full timeReporting to the Plant manager, the Process VIE will be responsible for running projects improving process controls in our Vinyl siding plant. The role will also support day-to-day production as well as lead problem solving activities to address production issues, interacting with all supporting departments in the plant. Additionally, the role will support...
-
QA Technician
2 weeks ago
Ontario, Canada Ice River Sustainable Solutions Full timeIce River Sustainable Solutions, Shelburne, Ontario, Canada Job Description Posted Monday, April 29, 2024 at 4:00 AM At Ice River Sustainable Solutions, our employees have incredible opportunities to work for an organization that is known for our forward-thinking innovation and eco-friendly design in products and packaging. Our culture is inclusive,...
-
Lead, Quality Reporting Operations
4 weeks ago
Ontario, Canada Ontario Health Full timeWant to make a difference in your career? Consider this opportunity. - Project/Program/Operations execution and delivery - Stakeholder relationship management Here is what you will be doing- Plays a leadership role in terms of content, process, and methods in the development and implementation of cancer screening quality projects and initiatives across...