Position Overview
We are seeking a highly experienced Quality Investigation Specialist to support Manufacturing Operations. This role is critical to ensuring compliance, product quality, and operational excellence by leading investigations related to Non-Conformances (NCRs), deviations, documentation errors, process failures, and quality events within GMP-regulated manufacturing environments.
The specialist will partner closely with Quality, Manufacturing, Engineering, and Compliance teams to drive robust investigations, root cause analysis, and corrective/preventive actions (CAPA). Key Responsibilities
Quality & Manufacturing Investigations

• Lead and execute investigations for NCRs, deviations, batch record discrepancies, OOS/OOT events, and process failures.
• Perform detailed root cause analysis using tools such as 5 Whys, Fishbone (Ishikawa), Pareto, FMEA, etc.
• Evaluate manufacturing processes, equipment performance, and material handling practices to determine failure modes.
• Review batch records, electronic systems, equipment logs, and quality data.
• Coordinate interviews with operators, supervisors, engineering, QA, and support teams to gather evidence and event timelines.

Documentation & Compliance

• Prepare clear, compliant, and audit-ready investigation reports, including documented rationale and impact assessments.
• Ensure investigations align with GMP, FDA, ISO, and internal Artorias procedures.
• Identify and document corrective and preventive actions (CAPA) and ensure timely implementation.
• Participate in internal audits, customer audits, and regulatory inspections by presenting or defending investigation outcomes.
• Ensure data integrity and maintain proper documentation control throughout all investigation activities.

Cross-Functional Collaboration

• Work closely with Quality, Operations, Engineering, EHS, and Supply Chain teams to understand processes and prevent recurrence.
• Support process improvements and quality initiatives to enhance reliability and reduce deviations.
• Identify trends and recurring issues by analyzing investigation data and performance metrics.

Required Qualifications

• Bachelor’s degree in Engineering, Science, Quality, Biotechnology, Industrial Engineering, or related field.
• 3–5 years of experience conducting investigations in a GMP-regulated manufacturing environment (pharma, medical device, food & beverage, biotech, nutraceuticals).
• Proven experience handling NCRs, deviations, CAPA, and root cause analysis.
• Strong knowledge of FDA, cGMP, ISO 9001/13485 standards, and quality systems.
• Excellent analytical, interviewing, and technical writing skills.
• Bilingual (English & Spanish) with strong communication skills.
• Ability to work independently in a fast-paced manufacturing environment and manage multiple investigations simultaneously.

Preferred Qualifications

• Experience using TrackWise, Veeva, EtQ Reliance, MasterControl, LIMS, or similar Quality Management Systems.
• Certifications in ASQ CQE, CQA, Six Sigma Yellow/Green Belt, or equivalent.
• Knowledge in process engineering, failure investigation, or quality system optimization.
• Experience in aseptic or clean manufacturing environments.

*Weil Group is proud to be an Equal Employment Opportunity Employer.*