Lead QC Micro Aseptic & EM Operations (On-Call)

Resilience; Port Union (OH); On-site; USD 60,000 - 86,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) with company match

Healthcare (medical, dental, vision)

Tuition reimbursement

Paid vacation and holidays

Job summary

Resilience is a technology-focused biomanufacturing company actively building a high-tech network of manufacturing solutions. The Analyst II, QC Micro - Aseptic role focuses on environmental monitoring execution, data review, and investigations at a sterile pharmaceutical site.

The position involves coordinating EM workload, training team members, and ensuring cGMP compliance, with on-site work and potential on-call requirements. A bachelor’s degree in science is preferred.

Qualifications

• Experience as a skilled specialist in sterile pharmaceutical production or QC.
• Ability to independently analyze EM data and identify trends.
• Ability to lead investigations and complete complex tasks with limited supervision.
• Experience training and guiding others in EM operations.
• Ability to coordinate daily activities of a team of technicians.

Responsibilities

• Maintain qualification to perform all EM technician responsibilities including aseptic gowning.
• Verify QC data and monitor for trends and abnormalities.
• Review production documentation for quality and cGMP compliance.
• Lead investigations and process-improvement activities with limited supervision.
• Schedule work and load pulls in the Environmental Monitoring System.

Skills

EM data analysis

Lead investigations

Team coordination

Self-direction

Training others

Education

Bachelor's degree in science

Tools

MODA

Novatek

EM software

Job description

Resilience is a technology-focused biomanufacturing company actively building a high-tech network of manufacturing solutions. The Analyst II, QC Micro - Aseptic role focuses on environmental monitoring execution, data review, and investigations at a sterile pharmaceutical site.

The position involves coordinating EM workload, training team members, and ensuring cGMP compliance, with on-site work and potential on-call requirements. A bachelor’s degree in science is preferred.