Senior QC Micro - Aseptic Compliance Leader

Resilience; Olde West Chester (OH); Hybrid; USD 75,000 - 116,000; Full time

Benefits offered by this job

Annual cash bonus

401(k) match

Healthcare benefits

Paid vacation

Job summary

Resilience is seeking a Senior Analyst, QC Micro - Aseptic to own the environmental monitoring program and ensure aseptic control compliance. You will serve as technical authority on EM for this site and partner with production, quality, and regulatory teams to uphold program integrity.

You will lead investigations, develop training content, and drive continuous improvement while ensuring cGMP practices and regulatory expectations are met across the environmental monitoring program.

Qualifications

• Demonstrated expertise in environmental monitoring, aseptic control, and regulatory compliance.
• Ability to own a technical program end-to-end and drive complex issues.
• Experience leading regulated pharma programs with cross-functional alignment.
• Strong communication and leadership skills.
• Excellent technical writing and problem-solving abilities.
• Proven project management and cross-functional collaboration.

Responsibilities

• Own environmental monitoring trending and EM/EMPQ updates, and deviations.
• Review EM data packages and lab documentation for cGMP compliance.
• Respond to compliance questions from regulators and internal teams.
• Develop and maintain the environmental monitoring program in regulatory compliance.
• Lead investigations, impact assessments, and mitigations.
• Represent the Aseptic Control Team on deviation/change committees.
• Lead process improvement activities and cross-functional alignment.
• Identify EM program gaps and drive solutions with stakeholders.

Skills

Environmental monitoring

Aseptic control

Regulatory compliance

Leadership

Technical writing

Project management

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in engineering or related

5+ years pharma QC or environmental monitoring

Tools

LEAN manufacturing

LDMS

Veeva

SAP

MODA

Job description

Resilience is seeking a Senior Analyst, QC Micro - Aseptic to own the environmental monitoring program and ensure aseptic control compliance. You will serve as technical authority on EM for this site and partner with production, quality, and regulatory teams to uphold program integrity.

You will lead investigations, develop training content, and drive continuous improvement while ensuring cGMP practices and regulatory expectations are met across the environmental monitoring program.