QC Senior Specialist - Analytical Science (Contract)

The QC Senior Specialist - Analytical Science has experience executing and/or reviewing quality control analysis in a GMP laboratory. This role is responsible for reviewing of small molecule analytical data, reports, methods, method validations/transfers, regulatory filings, and other documentation to support outsourced quality control testing. The Sr. Specialist may also manage trending of analytical data for continued process verification (CPV), investigations, change controls and may have potential vendor interaction. This is a temporary position and is designated as hybrid (on-site at least three days a week).

Key Duties and Responsibilities:

• Review raw data from routine QC analysis including HPLC, dissolution, KF, GC, bulk density, PSD, physical form (XRD), appearance, and identification
• QC check data in reports, regulatory filings, and other documentation
• Manage workflows and approval in Veeva document management system
• Distribute documents internally and externally as needed
• Perform analytical data trending to support continued process verification
• Document external analytical investigations (e.g. OOS, OOT & OOE)
• With supervision, interact with external laboratories to manage analytical documentation
• Other duties as assigned
  
  
  

Knowledge and Skills:

• Experience performing analytical tests or reviewing analytical lab data for small molecule drug substance, drug product intermediate, or drug product
• Prior experience working in a controlled environment (GMP or similar) Education and Experience:
• Prior experience with Microsoft Office, Veeva, JMP, Airtable, Smartsheet and DocuSign is advantageous
  
  
  

Requirements

Education and Experience:

• Bachelor's in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science with 5 years of experience OR
• Master's in Chemistry, Chemical Engineering, Pharmaceutical Chemistry, or other natural science with 2 years of experience