Job Title: Quality Control MicrobiologistJob 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 tests to support validation efforts to bring up a new manufacturing facility and other routine testing/lab support as needed. Tasks include but are 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.

Responsibilities

• Perform laboratory tests to support validation efforts and routine testing.

• Conduct endotoxin testing using gel clot and kinetic methods.

• Execute sub-visible particulate testing and sterility testing.

• Support media fills and other lab support activities as needed.

• Adhere to GMP documentation guidelines and internal standards.

• Collaborate with engineering, manufacturing, and quality teams.

Essential Skills

• 1-2 years of microbiology laboratory experience.

• 1-2 years of GMP experience.

• Pipetting experience in a regulated lab (microbiology or biology).

• Experience with endotoxin testing (gel clot or kinetic method).

• Proficiency in environmental monitoring, bioburden testing, LAL, kinetic and gel clot methods, quality control, sterility testing, and BET.

Additional Skills & Qualifications

• Bachelor's degree in Microbiology or Biology.

• Associate's degree with a minimum of 2 years GMP experience in a microbiology or environmental monitoring lab.

Work Environment

The role is primarily based in a microbiology lab environment, with most time spent on the bench within a large sterile injectable manufacturing facility. Some time will be spent in an office setting on a computer. The individual will work independently on their assigned sample load and interact with management and validation teams as needed. The standard work schedule is Monday to Friday, 1st shift day schedule, with a minimum of 40 hours per week. Flexibility for weekend and off-hours work might be required depending on the work cycle 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 & Inclusion

At 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 people

The 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.