POSITIONSenior Specialst, Quality Control (Microbiology)ABOUT THE COMPANY
New β Innovation Ltd. (NBI) is a preclinical stage life sciences organization in Burnaby, BC. Leveraging on our expertise in research and development, we are transforming drug discovery into clinical applications for unmet medical needs. We have ongoing collaborations with top universities worldwide on various research projects, with distinguished achievements in the areas of oncology, neurology, ischemic and hypoxic conditions.
Our state-of-the-art GMP manufacturing facilities and laboratories in Greater Vancouver are home to a growing team of professionals who are inspired to develop advanced life-saving hemoglobin-based therapeutics for the well-being of people.
Reporting to the Manager/ Senior Manager, Quality Control the incumbent will perform a variety of microbiological related functions and will be part of a team responsible for ensuring the integrity of the microbiology laboratory in support of a sterile pharmaceutical manufacturer.
- Proficiently 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 Standard Operating Procedures (SOP) in the microbiology laboratory to a high level with minimal editing required
- Review and perform validation of all microbiological test methods including writing protocols and reports to the required compliance level with minimal input from the manager
- 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 testing and equipment problems
- Act as a lead on technical or operational advice on microbiological topics
- Ensure that lab cleanliness and safety standards are maintained
- Perform other related tasks as needed
KNOWLEDGE, SKILLS AND ABILITIES
- Degree in Microbiology or recognised qualification in microbiology required
- 5 – 8+ years' experience in pharmaceutical or biological manufacturing industry with good knowledge of aseptic techniques and Good Documentation Practices (GDP)
- Strong working knowledge of Good Manufacturing Practices (GMPs) and have experience with execution of USP and EP test methodology (Microbial, Sterility, Endotoxin and Growth Promotion) for the manufacture of sterile products
- Must be able to gown as required in manufacturing areas
- Ability to competently apply professional concepts and specialised knowledge while receiving little instruction on day-to-day activities or new assignments
- Ability to work on multiple tasks at once by prioritizing based on departmental goals
- Excellent interpersonal skills, ability to work independently and in a team environment, detail oriented and 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
WHY JOIN NBI?
The best reason is because of our wonderful people and great work environment. If you are looking for a career with meaning and purpose, it's hard to beat working in life sciences. We provide an attractive compensation and benefits package which recognizes people for their contributions, and comprehensive training and career development opportunities which support our employees' growth with the company.
If you are interested in joining our team, we encourage you to APPLY today!
Posted: November 16, 2018
Closes: January 15, 2019