Job Title : QC Support

Job Type : Contract - Hybrid

Location : Holly Springs NC

*CAN ONLY SET UP W2 CONTRACTS - NO C2C*

Summary :

This senior-level role supports Analytical Method Validation, QC Equipment Commissioning, and GMP QC Laboratory readiness at there North Carolina facility. Ideal candidates bring 12+ years of QC and Analytical Validation experience and expertise in technical documentation, risk assessments, and lab process implementation.

Key Responsibilities :

Analytical Method Validation:

• Design, author, and execute protocols/reports for method validations, verifications, transfers, and stability studies.
• Apply core analytical techniques (e.g., HPLC/UPLC, SEC, ELISA, TOC, peptide mapping).

Laboratory Readiness:

• Create SOPs, O&M procedures, and Equipment Data Integrity Assessments
• Author Analytical Equipment Qualification Protocols and manage document changes in eQMS

Risk & Incident Management:

• Lead QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing
• Identify and resolve technical/operational gaps

Sample, Stability, and Reserve Management:

• Implement and refine stability and reserve programs for the new site

Qualifications :

Basic:

• Doctorate, Master's (3+ years), Bachelor's (5+ years), Associate (10+ years), or HS Diploma/GED (12+ years of clinical experience)

Preferred:

• 12+ years of QC and analytical validation experience
• Proven expertise in method validation/verification and technical writing in GMP environments

Key Skills:

• Technical writing, method validation, risk assessment, SOP development
• Proficiency in MS Office, eQMS, and document control.