Job Title: Microbiologist Support Specialist

Job Description

The Microbiologist Support Specialist will play a vital role in collaborating with the QC Particulate Lab group to bolster testing efforts on new critical projects at the site. This position involves supporting the particulate lab and QC group as they prepare for increased workload due to modernization efforts. Strong communication skills and the ability to work cross-functionally across engineering, manufacturing, and quality are essential.

Responsibilities

• Provide administrative and documentation support, ensuring the lab is audit-ready.
• Run and maintain batch records efficiently.
• Calibrate pipettes and instrumentation for lab analysts.
• Collaborate with IMEX to qualify and certify the lab to IMEX standards, and engage in process improvement initiatives.
• Maintain Excel files for lab documentation and assist with TSRs.
• Support sample testing as needed.

Essential Skills

• Bachelor's degree in microbiology, biology, or a related life science field.
• Proven experience with lab work in a regulated industry.
• Proficiency in pipetting and microbial testing.
• Strong organizational skills and familiarity with Excel.
• Experience in GMP lab operations, including particulate, sub-visible, gram staining, microscopy, and aseptic techniques.

Additional Skills & Qualifications

• Experience with Laboratory Information Management Systems (LIMS).

Work Environment

This role is primarily based in a microbiology lab environment within a large sterile injectable manufacturing facility. Some tasks will require working in an office setting using a computer, but the majority of time will be spent in microbiological laboratories. The position requires independent work on assigned tasks and interaction with management and validation teams as necessary. The standard schedule is Monday to Friday during the first shift day schedule, totaling a minimum of 40 hours per week. Flexibility for off-hours may be required depending on the work cycle and manufacturing runs. There is potential for a flexible schedule, such as working four ten-hour days or starting later in the day, once training is complete.