Quality Control Program Specialist
Job Description Summary
This position has the responsibility to assist in the maintenance of STEMCELL Technologies’ Quality Management System (QMS) and compliance to applicable regulations while ensuring quality products. The position provides the opportunity to exercise independent judgement in evaluating complex problems and applying current methodologies and best practices to resolve identified issues. This is a fixed term position.
Duties and Responsibilities
Assistant in maintaining corporate-wide Quality Management System (QMS) required for the sourcing and distribution of products which includes RUO and regulated products.
Participate in the development and improvement of Quality Control documents, including writing and revising certificate of analysis templates and reports.
Generate and review of certificate of analysis, batch records and other related documentation required for product release.
Review suppliers’ documentation to ensure completeness; set up, document and communicate product release specifications.
Apply good documentation practices to all document review.
Perform Enterprise Resource Planning (ERP) transactions related to product hold or release.
Generate information and data for new part set up and product launch.
Edit and write Standard Operating Procedures.
Generate and review Safety Data Sheets (SDS).
Support the Quality PLDP team in day-to-day activities.
Skills & Qualifications
Bachelor's degree or Technical Diploma in relevant field with typically 5-8+ years’ experience in Quality Control in the biotech industry or equivalent.
Proven ability to coordinate and execute responsibilities relating to Quality Control.
Excellent technical report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes.
Excellent communication skills both one on one and in a group setting.
Aptitude for learning and working with various electronic/technology platforms.
Highly organized and detail oriented; ability to question and not always be satisfied with the status quo.
Willingness to learn and assume the responsibilities.
Good interpersonal skills.
Self-motivated and independent work ethic.
Ability to handle multiple tasks in a fast-paced environment.
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!