Deviation Investigator

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Deviation Investigator
Location: Houston TX 77047
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite

Summary

The Deviation Investigator is responsible for independently initiating, investigating, and closing minor and low/medium-severity major process deviations, while supporting high-severity major and critical deviations under supervision. The role focuses on root cause analysis, Product Quality Impact (PQI), SISQP (Safety, Identity, Strength, Quality, Purity) assessment, risk evaluation, and implementation of corrective and preventive actions (CAPA). This position requires strong cross-functional collaboration, manufacturing-floor investigation experience, project management, customer communication, meeting facilitation, and the ability to manage multiple investigations and timelines in a pharmaceutical or biotechnology manufacturing environment.

Responsibilities

• Initiate, investigate, and close minor and low/medium-severity major process deviations independently.
• Support investigations of high-severity major and critical deviations under supervision.
• Gather and analyze data from multiple sources across the manufacturing site.
• Perform Root Cause Analysis (RCA), cause mapping, risk assessments, and trending analysis.
• Determine Product Quality Impact (PQI) and assess SISQP impact.
• Identify, develop, and implement Corrective and Preventive Actions (CAPA).
• Conduct associate interviews and observe manufacturing processes directly on the production floor.
• Manage multiple investigations, projects, priorities, and timelines simultaneously.
• Ensure investigations are completed within established timelines and escalate issues when necessary.
• Participate in daily management meetings and provide investigation status updates to leadership.
• Prepare PowerPoint presentations and other materials to communicate investigation findings and status to customers.
• Participate in alignment meetings, CAPA discussions, facilitated reviews, and comment-resolution activities.
• Facilitate meetings and align cross-functional review teams and subject matter experts on investigation strategies.
• Resolve conflicts and drive effective problem-solving across cross-functional teams.
• Participate in and occasionally lead the daily management system.
• Participate in or lead the Deviation Review Board.
• Maintain clear and effective communication with internal stakeholders, customers, SMEs, and leadership.
• Perform other duties as assigned.

Required Skills

• Deviation investigation experience in a pharmaceutical, biotechnology, or regulated manufacturing environment.
• Strong knowledge of Root Cause Analysis (RCA) and structured problem-solving methodologies.
• Knowledge of CAPA, risk assessment, cause mapping, and quality systems.
• Ability to assess Product Quality Impact (PQI) and SISQP considerations.
• Strong data-gathering, analytical, trending, and investigative skills.
• Experience conducting interviews and performing investigations on the manufacturing floor.
• Strong project management skills with the ability to manage multiple priorities and deadlines.
• Excellent written and verbal communication skills.
• Proficiency in preparing and presenting investigation findings using PowerPoint.
• Strong meeting facilitation and conflict-resolution skills.
• Ability to collaborate effectively with cross-functional teams, SMEs, customers, and leadership.
• Strong organizational skills and attention to detail.
• Ability to identify issues, escalate appropriately, and maintain investigation timelines.
• Ability to independently manage routine investigations and support complex investigations under supervision.

TekWissen Group is an equal opportunity employer supporting workforce diversity.