Job Description Summary
STEMCELL is looking for a Manager for the Quality Control, Microbiology / Enviromental Monitoring team to plan and lead daily operations.
This team is in charge of quality control microbiology testing to ensure materials and products meet with STEMCELL Quality standards.
This position is also responsible for managing the Environmental Monitoring (EM) program to support classified cleanroom operations according to industry standards and practices.
The QC Manager will act as subject matter expert for the EM program and microbiology practices. We are looking for a strong relationship builder to work within the QC team, as well as a cross functional link between QC and other groups at 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 QC lead for technology transfer including method qualification and validation activities.
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 (ISO13485 and cGMP) and customer needs.
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
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.
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 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)
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.