Quality Assurance Associate, Document Management and Training
Job Description Summary
The Quality Assurance Associate will maintain global STEMCELL records and documents related to the Quality Management System.
Duties and Responsibilities
- Assist in maintaining the corporate wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include RUO and regulated products.
- Maintain a centralized global wide system for all documents and records related to the Quality Management System
- Maintain existing controlled document system compliant to existing ISO 13485 standards including but not limited to electronic and hard copy procedures, Batch Records and Forms
- Manage inquiries related to the controlled document system
- Investigate and explore opportunities for improvement related to the electronic records management and controlled document systems
- Maintain and improve existing repository for all documents and records related to the Quality Management System
- Conduct company-wide training on any document and record related topics, as required
- Manage external records and relationship with archival vendor
- Maintain confidentiality on critical records and documents throughout the organization
- Organize manufacturing documents in support of product release activities
- Apply critical thinking to continuously improve the Quality Management System
- Collaborate with internal teams to represent compliance requirements related to document review
- Become the go to person for documentation expertise
- Support the Document Management and Training team in day to day activities
- Administration duties to support Quality team
- Education: Bachelor's Degree or Technical Diploma in relevant field.
- Experience: 2+ years of experience in the biotech or healthcare industry or equivalent
- Specialized knowledge: Library Sciences, Electronic Documentation Systems. Knowledge of regulatory requirements (e.g., ISO 13485, CE medical and IVD directives, cGMP, etc)
Knowledge, Skills and Abilities (KSAs):
- Proven ability to coordinate and execute responsibilities relating to Document Management.
- Excellent communication skills.
- Highly organized and detail oriented.
- Willingness to learn and assume new responsibilities.
- Aptitude for learning and working with various electronic/technology platforms.
- Good interpersonal skills; self-motivated and independent work ethic.
- Comfortable making presentations before groups.
- Ability to handle multiple tasks in a fast paced environment.
- Ability to question and not always be satisfied with the status quo.
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!