Senior QC Micro Analyst: Aseptic EM Leader
Resilience, Inc.
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Benefits offered by this job
Job summary
Resilience, Inc. is seeking a Senior Analyst, QC Micro – Aseptic in the United States to own the environmental monitoring program and drive aseptic control improvements.
You will independently manage EM program integrity, review data packages, and advise cross-functional teams on complex compliance matters. You will lead EM data reviews, mentor analysts, and collaborate with production and quality teams to ensure cGMP adherence while guiding investigations and deviations to successful
Qualifications
- Demonstrated ability to own a technical program end-to-end - setting the direction, proactively identifying gaps, and driving resolution of complex compliance problems without being directed to do so
- Demonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality; advise and improve independently
- Experience leading programs or projects in a regulated pharmaceutical setting with cross-functional alignment
Responsibilities
- Own environmental monitoring trending (monthly, quarterly, annual) and related documentation
- Serve as final technical reviewer and approver for EM data packages and for production/lab docs with cGMP determinations
- Respond to regulatory and compliance questions from agencies
- Develop and maintain the environmental monitoring program in regulatory compliance
- Lead complex investigations, impact assessments, and mitigations
- Represent the Aseptic Control Team on deviation/change management committees
- Lead process improvement activities and drive cross-functional alignment
- Identify gaps in the EM program and propose solutions
Skills
Education
Tools
Job description
Resilience, Inc. is seeking a Senior Analyst, QC Micro – Aseptic in the United States to own the environmental monitoring program and drive aseptic control improvements.
You will independently manage EM program integrity, review data packages, and advise cross-functional teams on complex compliance matters. You will lead EM data reviews, mentor analysts, and collaborate with production and quality teams to ensure cGMP adherence while guiding investigations and deviations to successful
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