Job Description Summary
The Senior Quality Control Analyst, Microbiology, is responsible for executing testing in the Microbiology laboratory at the STEMCELL Technologies sites and includes: Microbiological analysis of raw materials, in-process and finished products, bioburden testing of Purified water, Environmental Monitoring of controlled areas. The Senior Microbiologist is also responsible for writing and reviewing deviations, validation and verification of new methods as needed and documenting all work according to CGMP and CGLP standards.
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
- Environmental monitoring of controlled manufacturing and laboratory areas including, data trending.
- Sampling and analysis of purified water system for bioburden and endotoxin including data trending.
- Participate in non-routine testing as required.
- With minimal supervision able to qualify and execute test methods according to internal quality policies and regulatory guidelines
- Liaise with external parties such as contract laboratories and vendors, as instructed.
- Communicate with supervisors and co-workers to achieve departmental objectives and promote a safe and supportive working environment
- With minimal supervision able to qualify laboratory equipment to include authoring and execution of IQ/OQ/PQ protocols and reports.
- Document all work performed according to applicable Current Good Documentation Practices and CGLP’s.
- Identify and initiate laboratory investigations as needed. Support activities associated with investigations related to cGLP, cGMP product non-conformances, quality system activities, analytical processes that relate to QC Microbiology.
- Review laboratory test data, SOP’s, test procedures, method/equipment validation protocols, reports, and log books.
- Provide to QC Microbiology Manager, metrics and ideas for continuous improvement.
- Manage inventory needs for test materials and supplies.
- Ensures the laboratory is kept in a safe working environment and in compliance with laboratory safety standards.
- Perform additional tasks in relation to quality issues as agreed with the QC Manager.
- Escalate Quality issues to the QC Microbiology Manager and relevant Stemcell Technologies Leadership Team members.
- Qualify and execute test methods according to regulatory guidance such as USP/EP.
- Maintains knowledge of the latest regulatory guidelines and support the update of methods/process accordingly.
- Perform routinely cleaning and disinfection of laboratory benches cleaning with regards to cleaning schedules and good housekeeping standards
- Conduct additional testing in support of method validation/verification, method and tech transfer, routine and non-routine testing as part of investigation support.
- Serve as SME in interpretation of USP/EP, qualify and execute test methods according to regulatory guidance, making necessary updates accordingly.
- Partner with Quality Assurance, Engineering, Facilities, Manufacturing and other departments to ensure product testing and release of test results are performed in timely manner.
- Other duties as required.
- Bachelor Degree in Science or related discipline (biology or microbiology preferred)
- Three to five (3-5) years of experience in a GMP environment (pharmaceutical microbiology lab experiences an asset)
- Thorough understanding of CGMP’s USP/EP/ISO and other regulatory requirements for laboratory operations
- Proven ability to work effectively with peers in a team environment
- Occasional weeknight or weekend work may be required
- Note: position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. standing, walking, bending over, and repetitive use of legs are done occasionally.
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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