Job Title: QC Analytical Method Support

Location: 100% Onsite – Massachusetts (Local candidates only)

Duration: 6+ Months

Overview:

A pharmaceutical client is seeking a QC Analytical Method Support Consultant with strong hands-on lab experience to support analytical method documentation and QC processes.

Key Responsibilities:

• Write and maintain technical documents (SOPs, protocols, reports) for analytical methods.
• Ensure documentation complies with FDA, ICH, and internal quality standards.
• Act as the subject matter expert (SME) for analytical methods in QC.
• Support method troubleshooting and issue resolution in collaboration with cross-functional teams.
• Lead method transfer between labs/sites.
• Design and perform method validation according to regulatory guidelines.
• Interpret and report validation data.
• Perform routine QC testing (release and stability), including HPLC, ELISA, and potency assays.

Required Skills:

• 4+ years hands-on lab experience (3–4 years in pharma QC)
• Strong technical writing and QC documentation skills
• Deep knowledge of method development, transfer, and validation
• Hands-on experience with:
• HPLC
• ELISA (plate-based assays)
• Potency assays (ELISA and bioassays)

Nice to Have:

• Experience using Veeva (document management system)