Manager, Environmental Monitoring & Microbiology
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.
Job Description Summary
The Quality Control Manager, EM/Microbiology, will plan and lead the day to day operations related to the specific area to ensure the product meets STEMCELL’s Quality Standards. The EM/Micro QC Manager will establish strong relationships within the QC department and collaborate effectively in cross functional groups providing a link between Quality Control and other groups within STEMCELL technologies. This coordination and communication between departments will ensure quality control requirements are considered during the product life cycle.
DUTIES AND RESPONSIBILITIES
Establish and maintain various documents including SOPs, test methods, specifications, protocols, reports to support the Quality Management System as a whole according to STEMCELL compliance requirements (ISO13485 and cGMP) and customer needs.
Collaborate effectively across different functional groups to ensure QC requirements are communicated and being met.
Oversee the day to day operations to ensure timely product testing and product disposition according to QC procedures.
Develop and manage protocols for Environmental Monitoring of Cleanrooms.
Lead QC technology transfer including method qualification and validation activities.
Ensure the accuracy of all reports and other documents issued by Quality Control and that all components and products tested meet the appropriate specification for release
Act as QC Lead on deviation/investigation team(s) which includes facilitation, review, approval, tracking, and CAPA development and implementation.
Participate in and oversee Out-of-Specification (OOS) investigations and other non-conformances or troubleshooting investigations.
Ensure that all equipment is properly maintained and calibrated for use in the QC environment.
Monitor and gather relevant data or key performance indicators and create reports to track progress.
Implement measures for continuous improvement.
Lead, manage, coach, develop and evaluate direct reports through regular one-on-one and team meetings; conduct and document performance reviews; make compensation recommendations for direct reports in accordance with Company policies and practices.
Define job descriptions for new personnel, assists in staff hiring including resume review, interview process and candidate selection.
Communicate with colleagues to promote a safe and cooperative working environment.
- Minimum BSc degree in Microbiology, or equivalent and 5 years industry experience.
Minimum 3 years of industry experience in leadership position and demonstrated ability to achieve results.
Strong background and experience working in a GMP and ISO environment.
Strong knowledge of USP testing (i.e. Bioburden, Sterility, Endotoxin)
Experience working with Quality Management Systems (i.e. ISO13485, 21CFR 210, 211 & 820) and interpreting guidance documents including CFR, FDA and ICH
Broad knowledge of biological product development, testing and commercialization including Quality Control programs required to support ISO, cGMP and other regulated products.
Excellent attention-to-detail and record-keeping skills
Demonstrate initiative and critical thinking skills
Excellent verbal and written communication skills
Project Management experience an asset.
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!