Description:
Perform assigned quality control activities within the Microbiology Department to comply with applicable SOP's and cGMPs.
Employ aseptic techniques while performing Sterility, Endotoxin, Particulates and Bioburden testing of drug products, intermediates and raw materials per USP and Standard Operating Procedures (SOP) and Standard Test Methods (STM)
Perform in vivo biological performance testing of final product in support of product efficacy and quality per USP and Standard Test Methods (STM)
Perform Growth Promotion testing per USP Methods for various microbiological media
Prepare and analyze Biological Indicators in support of Validation and Qualification activities
Read plates to quantify microbial growth and subculture pure isolates as required
Data entry and review in Laboratory Management Systems (LIMS)
General laboratory housekeeping duties and maintenance of the department, premises, and equipment
Assist with laboratory investigations, root cause analysis, and implementation of corrective and preventative actions
Skills:
Aseptic technique, Microbiology, Laboratory, Environmental monitoring, Gmp, media preparation
Additional Skills & Qualifications:
Associate Degree or completion of college-level life science courses preferred.
1 or more years of relevant experience in quality / production in a cGMP / FDA regulated facility required
BS Degree in Science (Biology, Microbiology, Biochemistry)
Exposure to lab coursework in school and skills including aseptic technique, plating of samples, incubation, media preparation
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 for other accommodation options.