Program Lead, Quality Control Raw Materials
Job Description SummaryThe Program Lead, Quality Control Raw Materials is responsible for leading activities pertaining to raw material risk management and control within Quality Control and cross-functionally within STEMCELL. The position provides the opportunity to exercise independent judgement in evaluating complex problems and applying current methodologies and best practices to resolve identified issues. The Program Lead will work alongside highly motivated, knowledgeable and skilled individuals who have a passion for quality.
If you are a candidate who loves working in a dynamic, fast-paced environment, and enjoys interacting with multiple stakeholders within the company, this position is the perfect choice.
Duties and Responsibilities
Act as a QC RM subject matter expert in raw material risk management with an in-depth knowledge and understanding of the critical aspects of raw material management to support products through their lifecycle (from development to retirement).
Collaborate with the cross-functional teams (Procurement, Planning, R&D, PDV and QA) and support efforts in the raw material risk management program improvements.
Lead improvements in the processes of selection and approval of alternate raw materials for new and existing products, and ensure alignment with STEMCELL’s quality management system and regulatory requirements.
Manage and ensure all priorities concerning alternate approvals are handled swiftly to avoid stock out situations.
Prepare and approve raw material alternate reports for new and existing products manufactured under ISO9001 and ISO13485 quality management systems and cGMP regulations; prioritize report approvals based on risk assigned.
Create, revise and approve procedures pertaining to QC RM management.
Apply good documentation practices to all documents prepared, revised and reviewed.
Chair, facilitate or coordinate required meetings and prepare meeting minutes, provide regular updates on Alternate Assessment Program, including metrics.
Support the QC RM team in day to day activities.
May assist in staff hiring including resume review, interview process and candidate selection.
Promote a safe and cooperative working environment.
Bachelor's degree in relevant field with typically 8-12 years’ experience in Life Sciences or advanced degree with 5 years’ experience.
Effective planning and organizational skills with the ability to work with a high degree of accuracy.
Strong ability to identify gaps in processes and to make evidence-based decisions.
Effective oral and written communication skills as well as strong interpersonal skills.
Strong analytical and presentation skills including knowledge of spreadsheets and presentation tools.
Excellent technical report writing and ability to understand and interpret technical documents.
Proven ability to coordinate and execute responsibilities relating to Quality Control.
Proven ability to effectively collaborate, multitask and work in a fast paced environment.
Working knowledge and understanding of ISO 9001 and ISO 13485 quality management systems and cGMPs is an asset.
Experience using enterprise resource planning software, LIMS and /or eQMS systems.
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!