Quality Assurance Associate, Document Management and Training
Job Description SummaryThe Quality Assurance Associate within the QA Document Management and Training team at STEMCELL assists in the implementation and maintenance of the STEMCELL Quality Management System (QMS) and compliance to applicable regulations. It gives the opportunity to exercise independent judgment 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 this role in implementing best industry processes in a fast changing environment.
Duties and Responsibilities
Assist in maintaining a centralized global wide system for all documents, records and training related to the Quality Management System.
Process documents through the electronic document management system.
Manage inquiries related to the controlled document and quality training systems
Investigate and explore opportunities for improvement related to the records management as well as controlled document and quality training systems
Management of the Document Room including organization, filing and retrieval of documents as needed.
Process documents including but not limited to, scanning documents and completing the applicable metadata into the applicable document repository, hard copy document filing and fulfillment of document retrieval requests.
Manually sort through files, verify inventory for archiving and package files in boxes to be sent to offsite storage.
Conduct company-wide training on any document, record and quality training 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
Maintain and improve existing repository for all documents and records related to the Quality Management System
Identify and evaluate gaps in the Quality Management System that cause risk to the business. Provide recommendations and / or assist in activities to address the gaps.
Collaborate with internal teams to represent compliance requirements related to document review and quality training.
Provide training and technical support to all staff as related to the overall use and workflow of the controlled document and quality training within the electronic Quality Management System.
Provide support to the quality training program.
Support the Quality team in day-to-day activities.
Bachelor's Degree or Technical Diploma in relevant field.
2-4+ years of experience in the biotech or healthcare industry or equivalent
Specialized knowledge: Library Sciences, Electronic Documentation Systems.
Understand of key regulatory requirements (e.g., ISO 13485, CE medical and IVD directives, cGMP, etc) is required.
Ability to exercise judgment within undefined practices and procedures that may be incomplete or complex.
Proven ability to coordinate and execute responsibilities relating to Document Management and Training.
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.
Effective planning and organizational skills with the ability to work with a high degree of accuracy and recall.
Demonstrated ability in time management to ensure completion of tasks on a priority basis.
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.
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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!