Job Type

Full-time

Description

Alliance Biotech Solutions is seeking an experienced QC Microbiology Consultant to support a large-scale method transfer remediation and validation program at a pharmaceutical manufacturing facility. This role will focus on the assessment, remediation, transfer, and validation of legacy microbiological methods to ensure compliance with current GMP requirements and regulatory expectations.

Requirements

Responsibilities
• Evaluate and remediate legacy microbiological methods.
• Support method transfer and validation activities.
• Author protocols, risk assessments, and reports.
• Review historical data and identify compliance gaps.
• Troubleshoot microbiological methods and support investigations.
• Train analysts and support knowledge transfer activities.
• Generate GMP documentation and final reports.
• Partner with QC and QA teams to ensure regulatory compliance.

Experience/Skills
• Bachelor's degree in Microbiology, Biology, Biochemistry, or a related life sciences discipline.
• 5+ years of experience in Quality Control Microbiology within a pharmaceutical, biotechnology, or regulated GMP environment.
• Demonstrated experience supporting microbiological method transfers, method validation, method verification, or remediation activities.
• Strong experience authoring protocols, risk assessments, investigations, technical reports, and GMP documentation.
• Proven ability to troubleshoot microbiological methods and investigate atypical results.

Benefits & Compensation
• Industry competitive wage as a full-time employee
• Flexible Paid Time Off
• Medical, Dental and Vision Insurance with low employee cost
• Employer paid long term and short-term disability
• 401k plan with employer contributions

Salary Description

DOE