Specialist, Quality Control - Burnaby, Canada - New Beta innovation canada Ltd.

New Beta innovation canada Ltd.

Verified Company

Burnaby, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

ABOUT THE COMPANY

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.

POSITION OVERVIEW

Reporting to the Assistant Manager/ 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 microbiology laboratory in support of a sterile pharmaceutical manufacturer.

The incumbent will need to be flexible with their work hours and schedule, and may be required to perform shiftwork to fulfil manufacturing requirements.

Pre-employment medical and medical re-examination may be required annually to fulfil regulatory requirements.

Key Responsibilities

Perform sampling and routine microbiology testing, sterility testing and endotoxin testing in strict accordance with the appropriate testing methods for raw materials, packaging materials, inprocess 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 nonviable 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 Experience

Degree in Microbiology or recognised qualification in microbiology required
Minimum 3 years of 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 startup 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