Job Description Summary
The Quality Assurance Associate, Product Release is primarily responsible for the reviewing of product related manufacturing and testing documentation to ensure that the necessary pre-determined requirements are met for product release.
Other responsibilities include assisting in the maintenance of the STEMCELL Quality Management System (QMS) and compliance to applicable regulations via exercising independent judgement in evaluating complex problems and applying current methodologies and practices to resolve identified issues. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to implementing best industry processes in a fast changing environment.
This is a 12 month fixed term maternity leave position with the possibility of an extension.Job Description Duties and Responsibilities
- Reviews product manufacturing and testing documentation to ensure compliance with pre-established requirements.
- Support the maintenance of the Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include RUO, GMP, CE-IVD, and CE-EE products.
- Performs ERP transactions related to product release.
- Co-ordinates Quality interactions with some PLDP product suppliers to ensure accuracy of documentation and efficiency of product release.
- Applies critical thinking to continuously improve product release processes.
- Provides technical support to all staff as related to quality practices.
- Revision and creation of Standard Operating Procedures.
- Continued exposure to current quality thinking through reading, conferences and training courses.
- Participates in projects for continuous improvement initiatives within QA department and corporately
- BSc in one of life sciences (ie. Biochemistry, Immunology, Cell biology) or equivalent degree with 5+ years of industry experience
- Experience with quality management systems such as ISO 13485:2003 and cGMP manufacturing preferred
- Skills: Proven ability to coordinate and execute responsibilities related to Quality Assurance. Aptitude for learning and working with various electronic/technology platforms.
- Intermediate skill level in Microsoft office applications (Word, Excel, Powerpoint, Sharepoint, and Project)
- Experience with ERP/MRP software.
- Highly organized and detail oriented.
- Ability to question and not always be satisfied with the status quo.
- Self motivated, proven ability to work independently and as part of a team.
- Ability to handle multiple tasks in a fast paced environment.
- Excellent verbal and written communication skills.
This role requires vaccination against COVID-19 as per the current recommendations by local health authorities, including any COVID-19 boosters as recommended by local health authorities and where available.
STEMCELL Technologies Inc. is a privately-owned biotechnology company based in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as "Scientists Helping Scientists" - standing by our customers to provide outstanding products, technical support and training. We have over 1000 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.
To apply please select the apply button. You will then be directed to a login screen asking you to set up an account. You must set up an account in order to apply.
Create an account by selecting the create account button. You will then be asked for your email and to create a password. Your Password must be eight characters long, contain at least one special character, one capital letter, and a number. Once you have created your password you will be asked to upload your resume. Uploading your resume will provide the ability to auto-populate your application with information from your resume. If you prefer to manually complete all of the fields in the application you can do this by clicking next. You can upload your cover letter as an attachment in the attachments screen. Thank you for your interest in STEMCELL!