Senior QC Micro Lead, Aseptic & Environmental Monitoring
Resilience
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Benefits offered by this job
Job summary
Resilience is a technology-focused biomanufacturing company seeking a Senior Analyst, QC Micro - Aseptic to own the environmental monitoring program and ensure regulatory compliance. You will serve as the technical authority for EM, guiding investigations, reviews, and cross-functional alignment while mentoring the team.
The role emphasizes proactive program improvement, technical writing, and collaboration with production and quality units.
Qualifications
- Demonstrated expertise in environmental monitoring or aseptic control within pharma.
- Ability to own a technical program end-to-end and drive improvements without direction.
- Experience leading programs or projects in a regulated pharma setting with cross-functional alignment.
Responsibilities
- Own environmental monitoring trending and related documentation updates.
- Serve as final reviewer/approver for EM data packages and cGMP determinations.
- Develop and maintain EM program in regulatory compliance; drive investigations and improvements.
- Lead cross-functional teams and represent EM on deviation/change management committees.
- Provide technical training and coaching for EM and aseptic personnel.
- Fill in for manager on technical and compliance matters as needed.
Skills
Education
Tools
Job description
Resilience is a technology-focused biomanufacturing company seeking a Senior Analyst, QC Micro - Aseptic to own the environmental monitoring program and ensure regulatory compliance. You will serve as the technical authority for EM, guiding investigations, reviews, and cross-functional alignment while mentoring the team.
The role emphasizes proactive program improvement, technical writing, and collaboration with production and quality units.
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