Job Description Summary
The Senior Quality Assurance Specialist role at STEMCELL assists in achieving and maintaining compliance to regulation during design, development and technology transfer of regulated products and for related facilities. It gives the opportunity to exercise independent judgment in evaluating complex problems and applying professional judgement to achieve and maintain compliance. STEMCELL is a dynamic workplace that pursues cutting edge technologies and practices which translates to this role managing complex sources of data that require in-depth critical thinking and reviewing the impact to the department, organization and customers.Job Description Duties and Responsibilities
- Support product design, development and technology transfer activities of regulated products including review and approval of related documentation.
- Create and/or verify execution of quality strategies for new product introduction and GMP facility start up in support of regulatory filings and compliance.
- Oversees QA system/systems ensuring an effective balance of compliance and efficiency.
- Conducts or supports review of change controls, validation protocols, nonconformances, stability documentation, specifications and other quality related documentation.
- Conduct internal and external audits to measure compliance to relevant standards, directives, regulations and policies.
- Prepare, review, implement and improve procedures and processes across the organization to align with corporate initiatives and strategies with a focus on Quality systems that support and utilize the company's products.
- Communicate with Contract Manufacturing Organizations (CMOs and internal stakeholders to ensure compliance with applicable regulations and standards.
- Provide leadership and promote quality culture to all staff as related to quality practices and requirements.
- Maintain the corporate wide Quality Management System (QMS) required for the manufacture and distribution of STEMCELL products which include CE-IVD, CE-EE, RUO and GMP products.
- Collaborate with multiple internal disciplines and external product, process and program teams to represent compliance requirements within the QMS.
- Create and lead training initiatives specific to compliance for regulated products.
- Lead multi-disciplinary projects to support corporate initiatives.
- Identify and evaluate gaps in the QMS that cause risk to the business.
- Support the Quality team in day to day activities.
- Master's or Bachelor's Degree or Technical Diploma in relevant field.
- 10+ years' experience in quality assurance and/or regulatory and process improvement in the pharmaceutical, biotech industry or related industry. Experience in medical device. design/development, biocompatibility (ISO 10933), and/or adventitious agent testing regulation is an asset.
- In depth knowledge of regulatory requirements (e.g. 21 CFR 820, 21 CFR 210, 21 CFR 211) is required. Experience with regulatory inspection and audit is an asset.
- Experience in aseptic processing, sterile manufacturing and relevant process and facility controls. Experience in biologics or chemical manufacturing is an asset.
- 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.
- Excellent communication skills with demonstrated ability to collaborate with stakeholders of varying backgrounds and expertise.
- Demonstrated ability in project management and time management to ensure completion of tasks on a priority basis. Knowledge of project manager tools and process mapping are an asset.
- Exercises judgment within undefined practices and procedures that may be incomplete or complex.
- Comfortable making presentations before groups.
- Ability to question and not always be satisfied with the status quo.
- Eager to learn and assume new responsibilities.
- Good interpersonal skills; self-motivated and independent work ethic.
- Demonstrated ability to handle multiple tasks in a fast paced environment.
- Willing to commit to occasional travel globally, approximately once a quarter (post COVID-19).
This position will start as remote (working from home).
Candidates must be able to support occasional ad-hoc evening meetings to accommodate CMO time zones.
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!