Job Description
The Quality Control Microbiologist will be responsible for working with the QC Microbiology Final Product Testing group to support testing efforts on new critical projects at the site. This individual will perform a variety of laboratory testing to support validation efforts to bring up a new manufacturing facility, and other routine testing/lab support as needed. Including but not limited to endotoxin (gel clot and kinetic method), sub-visible particulate testing, sterility testing, and supporting media fills. Proper GMP documentation guidelines will be adhered to as well as our client's own standards and requirements. Strong communication skills and the ability to work cross functionally across engineering, manufacturing, and quality departments are essential.
ResponsibilitiesPerform laboratory testing to support validation efforts and routine lab support.Conduct endotoxin testing using gel clot and kinetic methods.Perform sub-visible particulate testing.Conduct sterility testing and support media fills.Adhere to GMP documentation guidelines and our client's standards.Communicate effectively and work cross functionally with engineering, manufacturing, and quality departments.Essential Skills1-2 years of experience in a microbiology laboratory.1-2 years of GMP experience.Pipetting experience in a regulated lab (microbiology or biology).Endotoxin testing experience (gel clot or kinetic method) (1-2 years).Experience with environmental monitoring.Experience with bioburden testing.Knowledge of LAL, kinetic, and gel clot methods.Quality control and sterility testing experience.Additional Skills & QualificationsBachelor's degree in Microbiology or Biology.Associates degree with a minimum of 2 years GMP experience in a microbiology or environmental monitoring lab.Work Environment
The position is primarily based in a microbiology lab environment, with most of the time spent on the bench in a large sterile injectable manufacturing facility. Some time will be spent in an office setting on a computer. The role requires independent work on assigned sample loads and interaction with management and validation teams as needed. The standard schedule is Monday to Friday, 1st shift day schedule, with a minimum of 40 hours per week. Flexibility for weekend and off-hour work may be required depending on the cycle of work and manufacturing runs.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.