Quality Assurance Specialist

We are seeking experienced QC Specialists to support a GMP pharmaceutical manufacturing site undergoing an active FDA improvement initiative. This role will focus on retrospective laboratory record review, documentation compliance, data integrity, and inspection readiness.

Key Responsibilities:

• Review historical laboratory equipment logbooks and controlled records for completeness and compliance.
• Evaluate laboratory data for potential duplicate test preparations and other quality concerns.
• Identify and document blank entries, missing information, documentation gaps, and GDP deficiencies.
• Perform independent reviews in accordance with approved procedures and established GMP/data integrity standards.
• Document objective observations without altering or rewriting historical records.
• Support a robust review process capable of withstanding FDA and regulatory scrutiny.
• Initiate or support deviations, investigations, and quality impact assessments when findings require further evaluation.

Skills &

Qualifications:

• 3–10+ years of QC laboratory experience in a GMP pharmaceutical, biologics, or API environment.
• Hands‑on experience reviewing laboratory documentation, equipment logbooks, and controlled records.
• Strong knowledge of GDP, ALCOA+, and data integrity principles.
• Familiarity with 21 CFR Parts 210/211.
• Comfortable performing high-volume manual and paper-based record reviews.
• FDA inspection readiness, remediation, Warning Letter, or consent decree experience is a plus.
• Experience with LIMS, CDS, or Empower is preferred.