Responsible for the organization and day to day operations of the microbiology laboratory. Ensures that the microbiology laboratory functions according to regulatory requirements and provides timely and efficient services to QLT's manufacturing facility and other required functions. Performs routine testing of raw materials, bulk intermediate and finished products, as well as stability samples (when available) according to established protocols and procedures.
1. Writes and revises SOPs and documentation to establish and maintain an environmental monitoring program.
2. Performs the day to day operations of the environmental monitoring program - collecting samples, performing testing and analyzing data and trending, including LIMS updates and second analyst reviews. Investigates non-conforming results.
3. Develops and validates microbiological and bacterial endotoxin methods for new drug substances, products or formulations.
4. Maintains the laboratory facilities and equipment in a clean, safe and productive manner. Orders laboratory supplies, reference standards and other consumables. Follows safety routines in all laboratory operations.
5. Tests raw materials, components and products in accordance with regulatory guidelines, SOP and required timelines. Learns and performs required testing following established procedures and records/reports results. Updates methods when required.
6. Performs aseptic sampling and testing of WFI, RO water, compressed air and nitrogen. Establishes methods, performs testing validation as required and investigates non-conforming results
7. Participates in various validation activities as required and trains new staff in SOPs where identified as subject matter expert.
8. Operates and maintains laboratory instruments and software in the microbiology and QC laboratory in a validated state.
9. Ensures that the responsibilities of the position are carried out in accordance with the Company's policies, empowerment and decision interaction requirements, operating and performance standards, and ethical and professional values.
10. Collaborates and interacts with others in a mutually supportive and cooperative manner that references the concept that staff at all levels are expected to seek ways in which they can support and assist others to achieve expected results as well as to be effective in their own accountability areas.
1. B.Sc. (Microbiology) with a minimum 5 years or M.Sc. (Microbiology) and a minimum of 3 years of experience in the pharmaceutical or biotechnology industry. Experience must include environmental monitoring testing and the use of statistical software for trending.
2. Current knowledge of microbiology and microbiological methods with a proven ability to develop and validate microbiological and bacterial endotoxin methods for new drug substances, products or formulations.
3. Strong working knowledge of cGMP regulations.
4. Sound knowledge of sterile manufacturing processes.
5. Strong troubleshooting and judgment skills. QLT Inc - 12 months ago