Supplier readiness specialist evaluating manufacturing systems, capacity, and operational risks for NFI. Supporting reliable production of sustainable buses and mobility solutions.
About the role
- Field Validation Specialist validating cGMP processes and equipment for Grifols' plasma donation centers. Executing qualifications, analyzing data, and ensuring regulatory compliance across Ontario sites.
Responsibilities
- Ensure current Good Manufacturing Practices (cGMP) and Health Canada/Grifols Quality Systems are followed during validation protocol performance, documentation, and review
- Travel to donor center sites to perform Operational Qualification/Performance Qualification testing
- Interact with Donor Center and Field Quality/Operations personnel to facilitate timely, documented validation approval
- Execute freezer installation, operational, and performance qualifications on-site
- Analyze validation data to ensure acceptance criteria are met and participate in writing validation summaries
- Communicate compliance and cGMP issues to Field Quality/Operations and Quality Assurance personnel
- Write and execute test cases for critical control points, user requirements, and functional designs
- Prepare validation reports for distribution
- Ensure project milestones and timelines are met
- Participate in evaluation and approval of processes, systems, and center equipment
- Prepare validation equipment for use and return evaluation
- Identify actions to add, remove, or revalidate processes, systems, and equipment
- Track and monitor process/system failures, events, equipment calibration due dates, and calibration failures
- Provide feedback to Donor Center management on requirements, results, and validation processes
- Prepare donor center staff and conduct validation training where applicable
Requirements
- Bachelor's degree
- Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment
- Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures
- Excellent quantitative and analytical skills
- Excellent oral and written communication skills
- Strong critical thinking and problem-solving skills
- Ability to identify errors and provide corrective action
- Ability to work with others in a team environment
- Knowledge of Microsoft Office applications and computer applications used in the Donor Centers
- Ability to work in office and laboratory/manufacturing environments
- Ability to use required personal protective equipment
- Ability to lift and carry objects up to 50 lbs
- Ability to follow written or oral instructions and procedures
- Ability to travel on-site to plasma donation centers up to 50%-75% as needed
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Préposé(e) aux bénéficiaires offrant soins d’hygiène, assistance et accompagnement aux résidents de Lokia. Travail en résidence, de jour, de soir et sur appel.
Senior Mobile Device Management Specialist supporting Intune, iOS, and Android compliance at RBC. Maintaining secure mobile policies for corporate and BYOD devices.
Quotation Tender Specialist leading RFQs and pricing for Hitachi Energy Canada’s high - voltage switchgear services. Coordinating customers, sales teams, factories, and suppliers.
Part - time retail shift leader supporting Canna Cabana, Canada’s cannabis retail chain, in Hinton. Supervising staff, customers, sales targets, compliance, and inventory on shift.
Retail Shift Leader overseeing daily operations, staff, sales, customer service, and inventory for Canna Cabana cannabis retail store. Supporting store management at High Tide Inc.
Medical Information Specialist RN handling medical and safety inquiries for ProPharma’s pharmaceutical clients. Documenting adverse events, product complaints, and regulatory information responses.
School bus attendant supporting Airdrie students with disabilities during safe school transportation. Assisting drivers, monitoring behavior, and communicating with guardians.
Part - time shift leader overseeing daily operations, sales, staff, and inventory at Canna Cabana, Canada’s largest cannabis retail chain. Supporting store management and customer service in Calgary.
Senior ITSM specialist governing Canadian Tire’s enterprise service portfolios and CMDB. Improving CSDM governance, data quality, lifecycle automation, and managed - services oversight.