Quality Control Manager, Microbiology and Environmental Monitoring
Job Description SummaryThe Quality Control Manager, Microbiology and Environmental Monitoring will plan and lead the daily operations related to QC Microbiology testing to ensure the materials/products meets STEMCELL’s Quality Standards. This position is also responsible for managing the Environmental Monitoring program to support classified cleanroom operations according to industry standards and practices. As a Quality Control Manager, you will act as subject matter expert for the environmental monitoring program and microbiology practices, and establish strong relationships both within the QC department and cross functionally providing a link between Quality Control and other groups within STEMCELL Technologies.
Duties and Responsibilities
Manage the day to day operations to ensure timely product testing and product disposition according to QC procedures.
Independently manage complex projects both within QC and cross functionally with other departments.
Collaborate with senior QC management on continuous improvement initiatives and to set strategic goals and direction for the QC micro team.
Develop and manage the Environmental Monitoring Program to support cleanroom operations.
Act as subject matter expert with respect to aseptic practices, gowning qualification, media fill inspection/qualification to help develop protocols/reports as required.
Act as QC Lead on deviation/investigation team(s) which includes facilitation, review, approval, tracking, and CAPA development and implementation.
Manage Out-of-Specification (OOS) investigations and other non-conformances or troubleshooting investigations.
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 (ISO 13485 and cGMP) and customer needs.
Monitor and gather relevant data or key performance indicators and create reports to track progress.
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.
Communicate with colleagues to promote a safe and cooperative working environment.
Perform other duties as required.
Skills & Qualifications
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 knowledge of Environmental Monitoring for cleanroom operations
Strong background and experience working in a GMP and ISO environment.
Strong knowledge of USP testing (i.e. Bioburden, Sterility, Endotoxin)
Strong knowledge with compliance, OOS, NCR, CAPA procedures
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 is an asset.
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.
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