Process Deviation Investigator - Biotech QA & CAPA Champion

TekWissen LLC; Houston (TX); On-site; USD 90,000 - 130,000; Part time

Job summary

TekWissen Group is seeking a Deviation Investigator for a 6-month onsite assignment in Houston, TX. You will independently initiate, investigate, and close deviations with emphasis on RCA, PQI, SISQP, and CAPA, while coordinating cross-functional teams.

The role requires strong data analysis, project management, and clear communication skills, plus practical experience conducting investigations on a manufacturing floor in a pharmaceutical or biotech environment.

Qualifications

• Deviation investigation experience in pharmaceutical/biotech environments.
• Strong RCA and structured problem-solving knowledge.
• Familiar with CAPA, risk assessment, and quality systems.
• Ability to assess PQI and SISQP considerations.
• Strong data-gathering, analytical, and investigative skills.
• Experience interviewing staff and investigating on the manufacturing floor.
• Project management skills to handle multiple priorities.
• Excellent written and verbal communication abilities.
• Proficient in preparing and presenting findings using PowerPoint.
• Ability to lead cross-functional review meetings and resolve conflicts.

Responsibilities

• Initiate, investigate, and close minor and low/medium-severity deviations independently.
• Support investigations of high-severity deviations under supervision.
• Gather and analyze data from multiple sources across the site.
• Perform RCA, cause mapping, risk assessments, and trending analysis.
• Determine PQI and SISQP impact.
• Identify, develop, and implement CAPA actions.
• Conduct associate interviews and observe manufacturing processes on the floor.
• Manage multiple investigations, projects, priorities, and timelines.
• Ensure investigations are completed within established timelines and escalate when needed.
• Prepare status updates for leadership and communicate findings clearly.
• Participate in CAPA discussions, reviews, and action item resolution.
• Facilitate cross-functional meetings and align investigation strategies.

Skills

Deviation investigation

Root Cause Analysis (RCA)

CAPA

PQI

SISQP assessment

Cross-functional collaboration

Project management

Data gathering & analysis

Communication skills

Documentation & presentation

Job description

TekWissen Group is seeking a Deviation Investigator for a 6-month onsite assignment in Houston, TX. You will independently initiate, investigate, and close deviations with emphasis on RCA, PQI, SISQP, and CAPA, while coordinating cross-functional teams.

The role requires strong data analysis, project management, and clear communication skills, plus practical experience conducting investigations on a manufacturing floor in a pharmaceutical or biotech environment.