Quality Records Investigator

Job Description

Job Title : Sr. Quality Records Investigator

Location : Houston, TX

Pay Rate : $24.82 / hr (W2)

Schedule : Monday–Friday | 8 : 00 AM – 5 : 00 PM

Work Type : 100% Onsite

Contract : Initial 6-month contract with extension potential

Job Summary

The Sr. Quality Records Investigator (Deviation Investigator / Initiator) is responsible for initiating, investigating, and completing Minor and low- to medium-severity Major process deviations independently, as well as supporting high-severity Major and Critical deviations under supervision. This role focuses on identifying root causes, assessing Product Quality Impact (PQI), and implementing corrective and preventive actions to ensure compliance and prevent recurrence in a regulated manufacturing environment.

Key Responsibilities

• Initiate, investigate, and close process deviations in accordance with quality system requirements and established timelines
• Perform Root Cause Analysis (RCA), cause mapping, risk assessments, and trending analysis
• Assess deviation impact to Safety, Identity, Strength, Quality, and Purity (SISQP)
• Identify, document, and support implementation of Corrective and Preventive Actions (CAPAs)
• Develop high-quality investigation reports using clear, concise technical writing suitable for an educated but non-expert audience
• Accurately document immediate actions, containment measures, and final investigation outcomes
• Address and resolve comments from internal stakeholders and external customers on investigation reports
• Gather investigation data from multiple site sources, including direct observation on the manufacturing floor
• Conduct associate interviews and observe manufacturing processes to support investigations
• Manage multiple investigations simultaneously while meeting standard timelines and escalation requirements
• Participate in daily management meetings to provide updates on deviation status and timelines
• Prepare and present PowerPoint updates for customers and leadership, including investigation progress and CAPA discussions
• Facilitate and participate in cross-functional meetings, aligning stakeholders on investigation strategy and resolution
• Support conflict resolution and problem-solving in a cross-functional environment
• Participate in or occasionally lead deviation review boards and daily management systems
• Perform additional duties as assigned

Required Skills & Competencies