Quality Control Analyst III, Microbiology EM (2nd Shift)

United States, Houston (Texas)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The purpose of this role is to support the Quality Control, Environmental Monitoring team in maintaining the cleanrooms for aseptic manufacturing for both At Rest and In Operation conditions. This role will also be central in all processes associated with environmental monitoring and integral with environmental investigations, excursion report writing, and general upkeep of the micro department.   

Shift hours are 12pm to 8pm CST 

Key responsibilities:
•    Performance of environmental monitoring. Level 3 gowning qualification is required. There will be events where many hours within the cleanroom at level 3 gowning is required. Work hours may vary dependent on the demands of individual manufacturing events.
•    Assist with the maintenance of laboratory/ media supplies and equipment.
•    Supports investigations for environmental excursions; assist and revise standard operational procedures, trend reports, deviations, and corrective actions.
•    Performs water sampling and gas testing.
•    Execute aseptic process validations, EM performance qualifications, and gowning qualifications.
•    Inspect aseptic process qualification units
•    Maintains compliance with all required training and assists with training of fellow analysts.
•    Performs other duties as assigned.  

Key requirements:
•    Bachelors degree required with concentration in Life Sciences or Microbiology/ Biology
•    Advanced years of experience in cGMP and QC Microbiology
•    Experienced working in pharmaceutical industry 
•    Must have strong communication skills, both written and oral. In addition, must have proficiency in Microsoft Word and Excel.
•    Experience with viable and non viable environmental and utility monitoring.
•    Experience with aseptic gowning in ISO5-ISO8 classified environments.
•    Demonstrated knowledge in general laboratory skills, environmental monitoring, and aseptic techniques.
•    Proficient in the use of spreadsheets, databases, and word processing software.
•    Prior experience with MODA FDC/EM a plus
•    Able to propose ideas during problem solving, root cause analysis, and process improvement events.
•    Provides suggestions for improvement to documentation and workflows.  
•    Writing is typically free of punctuation, spelling and grammatical errors
•    Provides timely, clear, and accurate updates without being prompted. 
•    Records test results and maintains raw data and accurate laboratory records.
•    Dependable and able to work well within a team.  Capable of effectively representing the department in meetings and on project teams
•    Leads by example and offers guidance to co-workers with respect to compliance and personal interactions.  
•    Interested in learning new things.  
•    Is optimistic and displays a positive attitude even during periods of adversity.
•    Is often the first to volunteer for specialized tasks.  
•    Is considered a go-to person for assistance.   
•    Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved.
•    Champions change speaking positively to and about others in all situations.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. 

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R34429