Career Opportunities in the Foresite Capital Network

ImmPACT-Bio is seeking a temporary Quality Control Microbiology Associate to support our CAR T cell therapy GMP clinical manufacturing facility in West Hills, CA.

You will work with the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. This position provides Quality Control microbiological testing for clinical manufactured product and will be responsible for performing environmental monitoring testing, raw material testing, and supporting final product release testing. This is an onsite, temporary position which reports to the Manager, Quality Control - Microbiology.

Primary Responsibilities:

• Perform and review environmental monitoring of cleanrooms including surface, viable air, non-viable air, and personnel monitoring.
• Support QC sample management as needed.
• Enumerate monitoring plates and review documentation.
• Supports the execution of studies or other departmental projects as needed.
• Routine maintenance of lab equipment and lab spaces.
• Support growth promotion and other applicable media for media qualifications.
• Support final product release assays which includes Endotoxin, Sterility, and Mycoplasma.
• Perform accurate data entry and trend data as needed.
• Assist in investigations regarding out of specifications (OOS) results, or environmental monitoring deviations as needed.
• Conducts procedure updates in QC lab and GMP reviews of logbooks.
• Supports other duties as assigned.

Qualifications:

• BS/BA degree in a science or health related field with 3+ years of experience – OR –

Equivalent amount of education and experience

• Experience in using equipment which support environmental monitoring.
• Experience in aseptic techniques and clean room operations
• Ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
• Ability to pass vision exam for visual inspection
• Proficient in MS Word, Excel, Power Point and other applications
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Ability to be flexible with schedule, work weekends and work overtime as needed
• Working knowledge of SOP writing and SOP change request is a plus
• Able to follow instructions and SOPs precisely and able to make/keep accurate documentation
• Able to learn new skills rapidly and achieve proficiency
• Detail-oriented with good written and verbal communication skills
• Good organizational and planning skills, and an ability to work efficiently
• Able to seek and accept input from more senior team members for the performance of assignments as needed
• Ability to solve problems of minor to moderate level and troubleshoot as necessary
• Team player with good interpersonal skills