Analyst II, QC Micro – Aseptic, Lead (Aseptic Microbiology)

Location: West Chester, Ohio, USA; onsite at a sterile pharmaceutical manufacturing site

Salary: $60,000–$86,250 per year

Company

hirify.global is a technology-focused biomanufacturing company developing end-to-end manufacturing solutions for medicines.

What you will do

• Perform and coordinate environmental monitoring in classified and non-classified areas up to Grade A, including aseptic gowning.
• Review QC data, production documentation, and logbooks for trends, abnormalities, completeness, and cGMP compliance.
• Lead investigations, root-cause analysis, corrective actions, and environmental monitoring process improvements.
• Schedule sampling work and coordinate workload assignments in the Environmental Monitoring System.
• Act as the operational link between QC Microbiology and Operations for scheduling and workload planning.
• Train technicians on systems, software, equipment, procedures, and environmental monitoring processes.

Requirements

• Experience as a skilled specialist in sterile pharmaceutical production or quality control.
• Ability to independently analyze environmental monitoring data, identify trends and root causes, and determine corrective actions.
• Experience leading investigations and complex tasks with limited supervision, applying aseptic operations and cGMP knowledge.
• Experience training and providing technical guidance to others.
• Ability to coordinate technicians’ daily activities and provide technical direction on environmental monitoring operations.
• Ability to provide 24/7 on-call support as needed and work a day-shift 12-hour 2/2/3 schedule.

Nice to have

• Bachelor’s degree in a scientific discipline.
• Two or more years of experience in pharmaceutical quality control or sterile manufacturing.
• Experience with MODA, Novatek, or equivalent environmental monitoring software.
• Experience in a LEAN manufacturing environment and knowledge of FDA policies and procedures.

Culture & Benefits

• Annual cash bonus program.
• 401(k) plan with company match.
• Medical, dental, and vision coverage, plus life and disability insurance.
• Paid vacation, holidays, and other leaves of absence.
• Tuition reimbursement and caregiving support.
• Visa and work authorization sponsorship or support is not available.