Scientific Support Specialist, Quality Processes
Job Description SummaryThe Scientific Support Specialist, Quality Processes role at STEMCELL supports the development, implementation, and daily operations of the quality processes employed in the Education & Product and Scientific Support department. It gives the opportunity to exercise independent judgment in evaluating complex problems and apply current methodologies and practices to resolve identified issues. This role is also expected to review and provide feedback on department member’s adherence to best practices and to lead by example to ensure that timely and appropriate actions are taking place.
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 on the department and organization.
Duties & Responsibilities
- Oversees effective documentation and implementation of the case logging processes in Scientific Support including, but not limited to, the complaint process.
- Performs risk assessments, files nonconformance records (NCRs) in ACE, and reviews and approves complaint case resolution.
- Acts as the departmental change coordinator (DCC); reviews and approves proposed changes supporting the NPI and change control processes.
- Produces and delivers the monthly complaint summary report to corporate members.
- Supports the generation of global and regional complaint presentations through the analysis of complaint case data sets and the generation of metrics summaries.
- Conducts data analysis for complaints to identify trends and brings them to the attention of the appropriate stakeholders.
- Investigates and explores opportunities for improvements related to STEMCELL’s complaint management processes.
- Consults with corporate subject matter experts to determine, negotiate, and agree on quality process standards and specifications.
- Represents the customer experience and perspective in all activities.
- Supports the development and coordination of Tech Notes and Product Notifications related to product changes and/or corrections, for distribution to customers.
- Supports internal investigations using industry-standard methods for root cause determinations and identification of meaningful corrective and preventative actions.
- Participates in internal and external audit activities.
- Prepare, review, implement and improve procedures and processes within the department that align with corporate initiatives and strategies with a focus on the quality systems that support STEMCELL products.
- Creates and leads training initiatives specific to quality compliance for ISO and or GMP products.
- Maintains confidentiality on critical records and documents.
- Supports the Scientific Support team in day-to-day activities; provides guidance/coaching and acts as a resource to junior members.
- May act as a liaison between internal Specialists, external departments, and QA/QC designates.
- Ad hoc projects and/or tasks as determined by the Manager.
- Bachelor’s degree with a minimum of 7 years of work experience or Master’s degree with a minimum of 5 years of work experience or Ph.D. with a minimum of 2 years of work experience in life sciences.
- 3+ years’ experience in quality assurance and/or regulatory and process improvement in the biotech industry or equivalent.
- Experience as a client service representative and/or within a research environment or biotechnology company is required.
- Good understanding of relevant regulatory and audit frameworks (e.g., ISO 13485, CE medical and IVD device directives, cGMP, etc.) is required.
- Demonstrated strength in analytical skills and critical thinking.
- Proficient at technical report writing with a strong ability to understand and analyze technical documents, processes, regulations, industry standards, procedures, and processes.
- Ability to take action on quality and compliance metrics and trends.
- Excellent communication and interpersonal skills; self-motivated and independent work ethic.
- Ability to think critically and effectively deal with change management.
- Strong presentation skills that support the effective dissemination of information to all levels of the organization.
- Demonstrated ability to leverage project and time management methodologies to ensure the completion of tasks on a priority basis.
- Demonstrated ability to meet short-term project deadlines.
- Experience transacting in electronic quality management (eQMS) and enterprise resource planning (ERP) software is required.
- Experience working with collaborative platforms such as Google Suite, Salesforce, and Confluence is required.
This role requires vaccination against COVID-19 as per the current recommendations by local health authorities, including any COVID-19 boosters as recommended by local health authorities and where available.
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!