Pharma Quality Investigator: Root-Cause & Compliance Lead

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 100,000 - 125,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA, seeks a Deviation Investigator to own manufacturing deviations at the Monroe aseptic facility under the Head of Operations and Head of Quality Systems. You will conduct root-cause analyses, implement corrective actions, and collaborate with cross-functional teams across dispensing, sterilization, filling, aseptic processes, and packaging to maintain CGMP compliance.

The role requires a BS/BA in science or engineering and at least three years in QA within

Qualifications

• BS/BA in Science or Engineering required.
• Minimum three years in Quality Assurance in pharma/biopharmaceuticals or medical devices.
• Strong GMP knowledge and regulatory guidance (FDA/ICH).
• Excellent communication and problem-solving abilities.

Responsibilities

• Log, triage, investigate, and resolve deviations per deadlines and regulatory requirements.
• Coordinate testing of reserved samples for investigations when applicable.
• Review relevant records (batch records, QC data, investigations).
• Conduct root cause analyses to drive corrective actions and preventive actions (CAPAs).
• Track quality system metrics and create trend analysis reports.
• Ensure CGMP compliance and maintain quality system procedures.
• Support site improvements and risk management for changes impacting CGMP.
• Prepare data for APR submissions for on-site manufactured products.
• Lead multiple investigations concurrently and communicate status to stakeholders.
• Train staff on processing quality events, deviations, and CAPA activities.
• Hold cross-functional meetings to discuss root causes and CAPA outcomes.
• Develop and author quality SOPs and related documents as needed.
• Perform quality reviews of documentation and processes.

Skills

Root cause analysis

GMP compliance

QA documentation

Cross-functional collaboration

Time management

Education

BS/BA in Science or Engineering

Job description

Glenmark Pharmaceuticals Inc., USA, seeks a Deviation Investigator to own manufacturing deviations at the Monroe aseptic facility under the Head of Operations and Head of Quality Systems. You will conduct root-cause analyses, implement corrective actions, and collaborate with cross-functional teams across dispensing, sterilization, filling, aseptic processes, and packaging to maintain CGMP compliance.

The role requires a BS/BA in science or engineering and at least three years in QA within