GMP Data Integrity QA Specialist - FDA Readiness

United Pharma; New Jersey; On-site; USD 70,000 - 110,000; Full time

Job summary

United Pharma is seeking experienced QC Specialists to support a GMP pharmaceutical site undergoing FDA improvement initiatives. This role focuses on retrospective laboratory record review, documentation compliance, data integrity, and inspection readiness.

Responsibilities include reviewing historical lab equipment logbooks, evaluating data for duplicate test preparations, identifying gaps, and supporting deviations and investigations as needed to withstand regulatory scrutiny.

Qualifications

• 3–10+ years of QC laboratory experience in GMP pharmaceutical, biologics or API environments.
• 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.
• Experience with high-volume manual and paper-based record reviews.
• FDA inspection readiness or related regulatory exposure is a plus.
• Experience with LIMS, CDS, or Empower is preferred.

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 per procedures and GMP/data integrity standards.
• Document objective observations without altering historical records.
• Support a robust review process capable of withstanding FDA scrutiny.
• Initiate or support deviations, investigations, and quality impact assessments when needed.

Skills

QC laboratory experience

GMP knowledge

Data integrity (ALCOA)

GDP familiarity

Documentation review

Regulatory readiness

FDA inspection readiness

Tools

LIMS

CDS

Empower

Job description

United Pharma is seeking experienced QC Specialists to support a GMP pharmaceutical site undergoing FDA improvement initiatives. This role focuses on retrospective laboratory record review, documentation compliance, data integrity, and inspection readiness.

Responsibilities include reviewing historical lab equipment logbooks, evaluating data for duplicate test preparations, identifying gaps, and supporting deviations and investigations as needed to withstand regulatory scrutiny.