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. #J-18808-Ljbffr United Pharma