Reporting to the Senior Manager, Quality Control the successful candidate will perform a variety of microbiological related functions and will be part of a team responsible for ensuring the integrity of the microbiology laboratory within a sterile GM environment. The ideal candidate will have a strong GMP background and the independence and flexibility to work within a startup environment.
This is a full-time, permanent position. Due to the nature of the role, weekend work and additional hours may be required from time-to-time to meet project requirements.
• Perform sampling and routine microbiology testing, sterility testing and endotoxin testing in strict accordance with the appropriate testing methods for raw materials, packaging materials, in-process and finished products• Perform sample collection and associated routine testing for environmental monitoring program (e.g. water for injection, pure steam, personnel, cleanroom sampling (viable and non-viable air, surface sampling)• Perform all microbiology related testing in support of process validation and cleaning validation• Perform microbial identification as required for routine testing and media fill procedures• Perform stability testing to support shelf life studies for the finished product• Develop/write and maintain Standard Operating Procedures (SOP) in the microbiology laboratory• Perform validation of all microbiological test methods including writing protocols and reports• Comply with Good Manufacturing Practices (GMP) and maintain strict and accurate quality control documentation of all test procedures and results• Perform equipment calibration as required for GMP compliance• Perform data compilation, trending and report writing on regular basis as required• Identify and troubleshoot equipment problems• Ensure lab cleanliness and safety standards are maintained• Perform other related tasks as needed
KNOWLEDGE, SKILLS AND ABILITIES
• Degree in Microbiology or recognized qualification in microbiology required• 3-7 years or more relevant work experience in pharmaceutical or biological manufacturing industry with good knowledge of aseptic techniques and good documentation practices• Have working knowledge of Good Manufacturing Practices (GMPs) and have experience with execution of USP and EP test methodology (Microbial, Sterility, Endotoxin, Growth Promotion) for the manufacture of sterile products• Must be able to gown as required in manufacturing areas• Excellent interpersonal skills, ability to work independently and in a team environment, detail oriented, organized and methodical in execution of tasks • Ability to problem solve with sound analytical thinking• Strong sense of pride in ownership and quality of work• Experience working in a start-up environment would be an asset