Senior Quality Assurance Specialist
Job Description SummaryIf you are a strong critical thinker looking to guide departmental policies, procedures, and processes, this Senior Quality Assurance Specialist could be the opportunity for you!
By utilizing your scientific knowledge and quality background, your input will support decisions pertaining to product releases, product launches, and document approvals. This role requires complex decisions in consultation with our Research and Development, and Technical Operations Teams. You will proactively identify compliance risks while designing and developing reports, ensuring the accuracy and completeness of documentation.
Duties and Responsibilities
Review, verification, processing of QMS records to ensure compliance to Quality Management Standards such as ISO 9001/13485/relevant GMPs and established procedures
Identify compliance and process issues/gaps to supervisors/managers. Proactively collaborate with stakeholders to identify any investigations and solutions
Ability to prioritize/manage/coordinate day to day tasks and escalate to supervisor/managers as required
Lead low complexity projects/initiatives
Represent QA for cross-functional projects/initiatives/meetings and raise/discuss potential issues with cross-functional team and supervisor/manager
Knowledge and Qualifications
Bachelor’s Degree in related field (e.g. biology, chemistry, etc.) with 5+ years in relevant work experience in quality and/or regulatory in the biotech industry or equivalent industry
Proven ability to coordinate and execute responsibilities relating to Quality Assurance using a high level of critical thinking
Excellent technical report writing and strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures and processes
Candidates must be able to support occasional ad-hoc evening meetings to accommodate CMO time zones
Willing to commit to occasional travel globally, approximately once a quarter (post COVID-19)
This role requires being fully vaccinated against COVID-19 as per STEMCELL’s vaccination policy, the current recommendations by local health authorities and as required by public health orders in place from time to time, including any COVID-19 boosters as recommended by local health authorities and as required by public health orders in place from time to time.
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!