QC Microbiology Consultant

ALLIANCE BIOTECH SOLUTIONS LLCWilson, NC
Onsite

About The Position

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

  • 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.

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.

Benefits

  • 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
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