Senior QC Micro Analyst — Aseptic EM Lead

Resilience, Inc.; Port Union (OH); Presencial; USD 75.000 - 116.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual bonus program

401(k) plan with company match

Comprehensive healthcare benefits

Paid vacation and holidays

Tuition reimbursement

Descripción de la vacante

Resilience, Inc. in the United States is seeking a Senior Analyst, QC Micro – Aseptic to own the environmental monitoring program and drive regulatory-compliant improvements across the site.

You will review EM data, approve packages, and escalate complex issues with cross-functional teams. The role requires strong leadership, technical writing, and problem-solving, with experience in LEAN manufacturing and familiarity with LDMS/Veeva, SAP, and MODA.

Formación

• Demonstrated technical expertise in environmental monitoring, aseptic control, or pharmaceutical quality.
• Ability to own a technical program end-to-end and drive improvements independently.
• Experience leading technical programs in a regulated pharma setting with cross-functional alignment.

Responsabilidades

• Environmental Monitoring Execution & Data Review, including EM trending and EMPQ.
• Serve as final technical reviewer/approver for EM data packages and deviations.
• Respond to compliance questions from regulators and internal teams.
• Develop and maintain the EM program in regulatory compliance.
• Lead complex investigations, impact assessments, and mitigations.
• Represent the Aseptic Control Team on deviation/change management.
• Lead process improvement activities and cross-functional alignment.
• Provide training and coaching on EM data interpretation and compliance.
• Fill in for manager on technical/compliance matters as needed.

Conocimientos

Environmental monitoring

Aseptic control

Cross-functional leadership

Regulatory compliance

Quality systems

Educación

Bachelor's degree in engineering, pharmacy, or related scientific discipline

Herramientas

LDMS

Veeva

SAP

MODA or equivalent

Descripción del empleo

Resilience, Inc. in the United States is seeking a Senior Analyst, QC Micro – Aseptic to own the environmental monitoring program and drive regulatory-compliant improvements across the site.

You will review EM data, approve packages, and escalate complex issues with cross-functional teams. The role requires strong leadership, technical writing, and problem-solving, with experience in LEAN manufacturing and familiarity with LDMS/Veeva, SAP, and MODA.