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STEMCELL Technologies

Quality Control Manager, Environmental Monitoring

Location
Vancouver, BC
Details
Full Time
6 days ago
Job Description Summary

The Quality Control Manager, Environmental Monitoring, is responsible for managing the Environmental Monitoring program to support classified cleanroom operations according to industry standards and practices. In this role you will act as the subject matter expert for the Environmental Monitoring program and establish strong relationships both within the QC department and cross functionally providing a link between Quality Control and other groups within STEMCELL technologies. Additionally, this position will act as Quality Control lead for expanding the program for a new facility and new cleanroom operations.

Job Description

Duties and Responsibilities
  • Manage the scheduling and activities for the Environmental Monitoring Program to support existing cleanroom operations including Clean Utilities (Purified Water System).
  • Develop and manage the Environmental Monitoring Program to support new facility and future cleanroom operations.
  • Manage the visual inspection program to support the Aseptic Process Simulation.
  • Act as QC lead on deviation/investigations related to all cleanrooms, including facilitation, review, approval, tracking, and CAPA development and implementation.
  • Coordinate with other team leaders to manage daily operations to ensure smooth operations of the Environmental Monitoring team, timely product testing and product disposition according to QC procedures.
  • Collaborate with senior QC management on continuous improvement initiatives and to set strategic goals and direction for the QC Environmental Monitoring team.
  • Establish and maintain various documents including SOPs, test methods, protocols, and 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.


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, including clean utilities.
  • Strong background and experience working in a GMP and ISO environment.
  • 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 verbal and written communication skills.


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.

#United

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!
Category
Quality Assurance