Quality Assurance Systems Specialist (Deviation Investigator Level II)

Lonza; Houston (TX); Sur place; Confidential; Plein temps

Résumé du poste

Lonza in Houston, TX seeks a Deviation Investigator Level II to lead root cause investigations and implement corrective actions ensuring safe medicine manufacturing. This site-based role emphasizes close collaboration and hands-on data gathering on the manufacturing floor with strong cross-functional communication.

You will manage multiple investigations, run RCA tools, assess SISQP impacts, and drive timely closure of CAPAs to prevent recurrence and safeguard product quality.

Qualifications

• Bachelor's degree in a scientific or engineering discipline (or equivalent practical experience).
• Proven experience initiating and leading deviation investigations within a regulated cGMP manufacturing environment.
• Demonstrated proficiency in Root Cause Analysis (RCA) tools (e.g., 5 Whys, Fishbone, Cause Mapping) and SISQP impact assessments.
• Ability to work comfortably on the active manufacturing floor for observational studies and interviews.
• Strong project management and time-management skills to lead multiple concurrent timelines and drive cross-functional conflict resolution.
• Excellent written and verbal communication skills, with experience facilitating cross-functional meetings and presenting to clients or internal stakeholders.

Responsabilités

• Initiate, investigate, and complete Minor and low/medium severity Major process deviations unassisted; complete high severity Major and Critical deviations under supervision to identify root causes and prevent recurrence.
• Gather data from site-wide sources, perform Root Cause Analysis (RCA), assess events for impact to Safety, Identity, Strength, Quality, and Purity (SISQP), run trending analyses, and conduct risk assessments and cause mapping.
• Manage multiple project timelines concurrently, adhere to standard execution schedules, and escape blockers appropriately for timely resolution.
• Work directly on the manufacturing floor to gather data, observe processes, and conduct associate interviews.
• Facilitate cross-functional alignment meetings, CAPA discussions, and comment resolutions while actively participating in or leading daily management updates and Deviation Review Boards (DRB).
• Routinely interact with customers by compiling presentations to communicate current investigation statuses and align on technical paths forward.
• Perform other duties as assigned.

Connaissances

Root Cause Analysis

Project Management

Communication

Manufacturing Floor Experience

Data Gathering & Analysis

Formation

Bachelor's degree in a scientific or engineering discipline

Outils

5 Whys

Fishbone Diagram

Cause Mapping

Description du poste

Deviation Investigator Level II

We are seeking a dedicated Deviation Investigator Level II to join our Quality Operations team. In this role, you will lead root cause investigations, determine product quality impacts, and implement corrective actions to support the safe manufacturing of life-changing medicines.

This is a fully site-based role. Working together in person supports close, real-time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Competitive hourly rate.

What you will do:

• Initiate, investigate, and complete Minor and low/medium severity Major process deviations unassisted; complete high severity Major and Critical deviations under supervision to identify root causes and prevent recurrence.

• Gather data from site-wide sources, perform Root Cause Analysis (RCA), assess events for impact to Safety, Identity, Strength, Quality, and Purity (SISQP), run trending analyses, and conduct risk assessments and cause mapping.

• Manage multiple project timelines concurrently, adhere to standard execution schedules, and escape blockers appropriately for timely resolution.

• Work directly on the manufacturing floor to gather data, observe processes, and conduct associate interviews.

• Facilitate cross-functional alignment meetings, CAPA discussions, and comment resolutions while actively participating in or leading daily management updates and Deviation Review Boards (DRB).

• Routinely interact with customers by compiling presentations to communicate current investigation statuses and align on technical paths forward.

• Perform other duties as assigned.

What we are looking for:

• Bachelor's degree in a scientific or engineering discipline (or equivalent practical experience).

• Proven experience initiating and leading deviation investigations within a regulated cGMP manufacturing environment.

• Demonstrated proficiency in Root Cause Analysis (RCA) tools (e.g., 5 Whys, Fishbone, Cause Mapping) and SISQP impact assessments.

• Ability to work comfortably on the active manufacturing floor for observational studies and interviews.

• Strong project management and time-management skills to lead multiple concurrent timelines and drive cross-functional conflict resolution.

• Excellent written and verbal communication skills, with experience facilitating cross-functional meetings and presenting to clients or internal stakeholders.

About Lonza

At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work they want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.