Senior Quality Control Analyst
Job Description Summary
The Senior Quality Control Analyst, Microbiology will conduct a microbiological analysis of raw materials, in-process, and finished products. Environmental monitoring of controlled cleanroom areas in compliance with STEMCELL's quality management system, GMP and ISO standards. The Senior QC Analyst is also responsible for writing and reviewing deviations as needed, validation and verification of new methods, laboratory maintenance and assisting in the resolution of non-conformances.
Duties and Responsibilities
- Microbiological analysis of raw materials, in-process, and finished products according to standard operating procedures. The testing includes sterility, endotoxin, bioburden, and mycoplasma.
- Perform Environmental Monitoring (EM) of controlled manufacturing and laboratory areas in addition to EM data trending.
- Sampling of purified water system for bioburden, endotoxin, TOC and conductivity testing.
- Analysis of purified water system for bioburden and endotoxin including data trending.
- Participate in non-routine testing as may be required (Bubble Test).
- With minimal supervision able to qualify and execute test methods according to regulatory guidelines.
- Preparation, completion, and review of QC testing data and records.
- The operation, cleaning, and maintenance of microbiology laboratory, including equipment.
- Purchasing and inventory management of laboratory supplies.
- Liaise with external parties such as contract laboratories and vendors, as instructed.
- Write and review protocols, reports and standard operating procedures.
- Participate in method development and validation, as required.
- Demonstrate sound judgment when encountering atypical situations and out-of-specification results, participate in non-conformity investigations.
- Participate in multi-department teams to resolve problems, increase efficiencies and improve processes.
- Communicate with supervisors and co-workers to achieve departmental objectives and promote a safe and supportive working environment.
- May be designated as a trainer for new analysts inapplicable standard operating procedures.
- Occasional weeknight or weekend work may be required.
- Minimum BSc degree in Microbiology, or equivalent.
- Minimum 3-5 years of lab-based work experience. (co-op work experience is applicable).
- Experience in GMP environment and Quality Control laboratory performing sterility, endotoxin, and environmental monitoring. (an asset).
- Working knowledge of USP test methods in microbiology an asset.
- Demonstrated ability in writing protocols and reports ( an asset).
- Excellent aseptic technique.
- Excellent attention-to-detail and record-keeping skills.
- Demonstrate initiative and critical thinking skills.
- Excellent verbal and written communication skills.
- Demonstrated ability to work cooperatively in a team setting.
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!