QC Associate II, Microbiology

Title: QC Associate II, Microbiology

Location: Waltham, MA

Reports to: Manager, QC Microbiology

The Role:

The QC Associate II, Microbiology is responsible for performing routine testing and project work in the QC microbiology laboratory at our Waltham facility.

Here's What You'll Do:

• Conducts environmental monitoring sampling of manufacturing cleanroom areas and utility systems (WFI and Compressed gases)
• Perform QC microbiological assays such as: appearance, bioburden, endotoxin, sterility, and TOC/Conductivity assays.
• Accurately records, summarizes, trends and reviews data in accordance with cGMPs and SOPs
• Perform investigations and execution of method qualifications
• Draft validation protocols and reports
• Author and revise SOPs and training documents
• Generate and present trend data/reports
• Coordinate data for batch release
• General Housekeeping of laboratories
• Conduct training

Requirements:

• Bachelor's degree in technical discipline (Microbiology/Biology or related field) with 3 to 5 years of experience in a GMP manufacturing facility
• Advance knowledge of microbiological compendial methods and techniques such as but not limited to: subculturing, Gram Stain, Aseptic Techniques, Aseptic Gowning, operation in biological safety cabinets, rapid microbiological methods
• Ability to lift 25 lbs. and pass aseptic gowning qualifications
• Ability to gown and work in cleanroom environment
• Ability to communicate and manage projects with minimal guidance
• Experience conducting and writing up laboratory and environmental monitoring investigations
• Experience designing lab experiments, drafting of validation protocols and reports
• Experience analyzing data and trends using statistical software
• Ability to train others on methods and routine lab work
• Excellent organizational and time management skills.
• Knowledge of word, excel, PowerPoint, laboratory data analysis systems (LIMS) preferred.
• Experience in cell and gene therapy manufacturing environment a plus

NOTE: Weekend and second shift hours required

Why join ElevateBio?

ElevateBio is accelerating the future of biotechnology; developing the next-generation of cell, viral and regenerative medicine therapeutics for the treatment of severe diseases. We have launched a revolutionary new model that integrates innovators, infrastructure and capital to effectively develop cell, gene and related therapies for patients with severe and life-threatening disorders. With plans for a cutting-edge laboratory and manufacturing center already underway, we're building a world-class organization lead by expert talent with bench-to-bedside capabilities. ElevateBio is also a leader in corporate philanthropy and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world.

At the heart of the ElevateBio platform is ElevateBio Base Camp, a state-of-the-art research, development and manufacturing center for innovation in the Greater Boston Area to be staffed with a world-class team of scientists.

Our Vision:
Next-generation product development for advanced therapies supported by global bench-to-bedside expertise shared across our portfolio of companies

ElevateBio is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. ElevateBio will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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