Senior Aseptic QC Micro Lead

Resilience, Inc.; Ohio; Vor Ort; USD 75.000 - 116.000; Vollzeit

Benefits dieser Stelle

Annual bonus

401(k) with company match

Comprehensive benefits package

Paid time off

Zusammenfassung

Resilience, Inc. is seeking a Senior Specialist, Aseptic Control in West Chester, OH. This role leads the environmental monitoring program, ensures cGMP compliance, and guides cross-functional teams in complex investigations and improvements.

The position requires strong leadership, technical expertise in EM/aseptic control, and the ability to influence across departments. Expect a comprehensive rewards package and a commitment to quality and compliance.

Qualifikationen

• Minimum: bachelor’s degree in engineering, pharmacy, or a related field.
• 5+ years in pharmaceutical QC or environmental monitoring.
• Strong communication and leadership skills.
• LEAN manufacturing experience preferred.
• Experience with LDMS, Veeva, SAP, or MODA is a plus.

Aufgaben

• Own environmental monitoring trending and EM data reviews.
• Review EM data packages and cGMP determinations.
• Lead complex investigations and cross-functional improvements.
• Provide training and coaching to EM and aseptic teams.
• Support deviation and change management processes.
• Represent EM on cross-functional committees.

Kenntnisse

Environmental monitoring

Aseptic control

Regulatory compliance

Leadership

Project management

Ausbildung

Bachelor's degree in engineering or pharmacy

Tools

LDMS

Veeva

SAP

MODA

Jobbeschreibung

Resilience, Inc. is seeking a Senior Specialist, Aseptic Control in West Chester, OH. This role leads the environmental monitoring program, ensures cGMP compliance, and guides cross-functional teams in complex investigations and improvements.

The position requires strong leadership, technical expertise in EM/aseptic control, and the ability to influence across departments. Expect a comprehensive rewards package and a commitment to quality and compliance.