ALLIANCE BIOTECH SOLUTIONS LLC
Wilson, NC
Description:
Alliance Biotech Solutions is seeking an experienced Analytical Chemistry SME 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 analytical methods to ensure compliance with current GMP requirements and regulatory expectations.
Requirements:
• Evaluate and remediate legacy analytical methods and supporting documentation. • Support method transfer and validation activities. • Author protocols, risk assessments, and technical reports. • Review historical data and identify documentation or compliance gaps. • Troubleshoot analytical 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 Chemistry, Analytical...