Sr. Quality Records Investigator

SGS Consulting; Austin (TX); On-site; USD 95,000 - 140,000; Full time

Job summary

SGS Consulting in Austin, TX is seeking a Senior Quality Investigator to translate complex scientific events into concise reports. You will gather data, perform RCA to identify likely causes, assess impact on SISQP, and propose CAPA actions to prevent recurrence on the manufacturing floor.

The role requires managing multiple investigations and timelines, facilitating risk assessments, mapping causes, and presenting findings in PowerPoint to leadership.

Qualifications

• Experience conducting investigations in a manufacturing or scientific setting.
• Ability to translate complex data into concise reports for diverse audiences.
• Strong skills in RCA, CAPA, and risk assessment.

Responsibilities

• Technical writing to produce concise reports for educated but uninformed readers.
• Gather data from multiple sources and perform RCA to identify the most likely cause of deviations.
• Assess event impact on SISQP and propose corrective and preventative actions (CAPA).
• Conduct risk assessments, cause mapping, and perform trending analysis.
• Lead or participate in daily management meetings and deviation review boards.
• Facilitate meetings, communicate status via PowerPoint, and coordinate cross-functional teams.

Skills

Investigations

CAPA

Root Cause Analysis

Tools

PowerPoint

Job description

Job Responsibilities

Technical writing for the educated but uninformed reader, translate difficult and complex scientific events into a brief and cohesive report as a finished product. Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report. Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing. Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline, and esc… actions appropriately for resolution in a timely manner. Participation in the Daily Management meetings to update leadership or current deviation statuses.Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution.Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews. Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty. Attendance and occasional leadership of the daily management system and participating/leading the deviation review board.Perform other duties as assigned.

Skills

Investigations CAPA Root Cause Analysis (RCA)