GMP Deviation Investigator & QA Champion

Glenmarkpharma; Monroe (NC); On-site; USD 85,000 - 105,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA in Monroe, NC, seeks a Deviation Investigator to own and investigate manufacturing deviations under the Head of Operations and Head of Quality Systems. You will perform root cause analyses, identify corrective actions, and ensure timely closure of investigations across manufacturing processes.

The role collaborates with cross-functional teams spanning dispensing, compounding, sterilization, filling, packaging, and quality systems.

Qualifications

• BS/BA in Science, Engineering, Pharmaceutical Sciences, or equivalent.
• Minimum three years in Quality Assurance in the pharmaceutical/biopharmaceutical/medical device industry or a combination of education and experience.
• Strong understanding of GMPs and regulatory guidance (FDA, ICH).

Responsibilities

• Log and triage investigations, ensure timely closure per deadlines and regulatory requirements.
• Coordinate testing of retained samples for investigations where applicable.
• Review batch records, quality control data, and quality investigations.
• Conduct root cause analyses and initiate corrective and preventative actions.
• Track quality system metrics and produce trend analyses.
• Ensure CGMP compliance across quality systems and procedures.
• Support site projects to improve quality and efficiency.
• Assess changes for CGMP impact using risk management tools.
• Prepare data for APR submissions for on-site products.
• Manage multiple investigations concurrently and communicate status to stakeholders.
• Train staff on processing quality events, deviations, and CAPAs.
• Lead cross-functional meetings to discuss root cause analysis and outcomes.
• Develop/author quality SOPs and related documents.
• Perform quality reviews of documentation and processes.
• Provide trend reports of quality events.

Skills

GMP knowledge

Regulatory guidance

Root cause analysis

Time management

Cross-functional collaboration

Communication

Problem solving

Attention to detail

Education

BS/BA in Science/Engineering/Pharmaceutical Sciences

Job description

Glenmark Pharmaceuticals Inc., USA in Monroe, NC, seeks a Deviation Investigator to own and investigate manufacturing deviations under the Head of Operations and Head of Quality Systems. You will perform root cause analyses, identify corrective actions, and ensure timely closure of investigations across manufacturing processes.

The role collaborates with cross-functional teams spanning dispensing, compounding, sterilization, filling, packaging, and quality systems.