Lead QC Microbiology Analyst – Aseptic
Resilience US
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Job summary
Resilience is a technology-focused biomanufacturing company seeking a Senior Analyst, QC Micro - Aseptic. You will own the environmental monitoring program, review data, and advise on complex compliance matters across cross-functional teams.
The role emphasizes independent program ownership, continuous improvement, and proactive regulatory engagement in a fast-paced, regulated setting.
Qualifications
- Experience in environmental monitoring and aseptic control in regulated pharma settings.
- Ability to own a technical program end-to-end and drive improvements.
- Strong communication and leadership skills.
- Experience leading cross-functional projects in a regulated environment.
- Proven ability to influence decisions without formal authority.
Responsibilities
- Own environmental monitoring trending and related documentation.
- Review EM data packages and production/lab docs for cGMP compliance.
- Respond to regulatory and compliance inquiries.
- Develop and maintain EM program in regulatory compliance.
- Lead investigations, impact assessments, and mitigations.
- Represent EM on deviation/change management committees.
- Lead process improvement activities.
- Identify EM program gaps and drive cross-functional solutions.
Skills
Education
Tools
Job description
Resilience is a technology-focused biomanufacturing company seeking a Senior Analyst, QC Micro - Aseptic. You will own the environmental monitoring program, review data, and advise on complex compliance matters across cross-functional teams.
The role emphasizes independent program ownership, continuous improvement, and proactive regulatory engagement in a fast-paced, regulated setting.
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