Senior QC Micro - Aseptic Environmental Lead

Resilience; Olde West Chester (OH); Sur place; USD 75 000 - 116 000; Plein temps

Résumé du poste

Resilience is a technology-focused biomanufacturing company transforming how medicine is made. The Senior Analyst, QC Micro - Aseptic leads the environmental monitoring program and aseptic control, ensuring program integrity and regulatory compliance.

Responsibilities include performing EM data review, leading investigations, and driving cross-functional improvements, with collaboration across production and lab teams. Strong leadership and technical writing are essential for success.

Qualifications

• Demonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality.
• Own a technical program end-to-end with proactive gap identification and resolution.
• Experience leading technical programs or projects in a regulated pharmaceutical setting.

Responsabilités

• Own environmental monitoring trending, EMPQ, deviations and investigations.
• Serve as final reviewer/approver for EM data packages and cGMP determinations.
• Respond to regulatory questions and develop EM program in regulatory compliance.
• Lead investigations, impact assessments, and mitigations.
• Represent Aseptic Control Team on deviation/change management committees.
• Lead process improvement activities and drive cross-functional alignment.

Connaissances

Environmental monitoring

Aseptic control

Regulatory compliance

Communication

Leadership

Project management

Technical writing

Problem-solving

Formation

Bachelor's degree in engineering/pharma

Outils

LDMS

Veeva

Microsoft Office

MODA

SAP

Description du poste

Resilience is a technology-focused biomanufacturing company transforming how medicine is made. The Senior Analyst, QC Micro - Aseptic leads the environmental monitoring program and aseptic control, ensuring program integrity and regulatory compliance.

Responsibilities include performing EM data review, leading investigations, and driving cross-functional improvements, with collaboration across production and lab teams. Strong leadership and technical writing are essential for success.