Sterility Assurance Lead - GMP Compliance & CAPA Expert

Stark Pharma Solutions Inc; Greenville (NC); Presencial; USD 120.000 - 160.000; Jornada completa

Descripción de la vacante

Stark Pharma Solutions Inc, a life sciences staffing and consulting firm, seeks a Senior Consultant for sterility assurance in a Greenville, North Carolina sterile manufacturing setting. The role covers contamination control, data integrity, CAPA management and close collaboration with Manufacturing, Quality and Regulatory teams.

The ideal candidate has 3+ years of post-graduate experience in pharma quality or GMP compliance, strong writing skills, and the ability to work onsite in Greenville.

Formación

• Bachelor's degree in a scientific discipline (Microbiology/Biology/Chemistry/Engineering).
• 3–5+ years of experience in pharma quality, sterility assurance or GMP compliance.
• Experience in sterile or aseptic manufacturing.
• Strong working knowledge of cGMP and data integrity (ALCOA+).
• Experience supporting FDA inspections or remediation activities.

Responsabilidades

• Provide sterility assurance oversight for aseptic manufacturing operations.
• Support contamination control strategy and environmental monitoring programs.
• Lead and support deviation investigations, OOS/OOT investigations and root cause analysis.
• Author, review and drive CAPAs through to closure with effectiveness checks.
• Support FDA remediation commitments and ensure timely closure of observations.
• Apply data integrity principles (ALCOA+) across records and docs.
• Review batch records and support product disposition activities.
• Prepare evidence packages for regulatory inspections and maintain SOPs and quality records.

Conocimientos

Sterility assurance

GMP compliance

Environmental monitoring

Educación

Bachelor's degree in Microbiology/Biology/Chemistry/Engineering

Herramientas

cGMP knowledge

21 CFR Parts 210-211

21 CFR Part 11

Descripción del empleo

Stark Pharma Solutions Inc, a life sciences staffing and consulting firm, seeks a Senior Consultant for sterility assurance in a Greenville, North Carolina sterile manufacturing setting. The role covers contamination control, data integrity, CAPA management and close collaboration with Manufacturing, Quality and Regulatory teams.

The ideal candidate has 3+ years of post-graduate experience in pharma quality or GMP compliance, strong writing skills, and the ability to work onsite in Greenville.