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QA Investigator (GMP)

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Actalent

10d ago

  • Job
    Full-time
    Mid & Senior Level
  • Science
  • Saint Louis

AI generated summary

  • You must have expertise in root cause and chemical analysis, SOP development, CAPA management, data analysis, collaboration, and strong problem-solving skills with attention to detail.
  • You will lead investigations into failures and complaints, analyze data, develop SOPs, collaborate on corrective actions, and report on metrics and trends in quality meetings.

Requirements

  • Root Cause Analysis
  • Chemical Analysis
  • SOP Development
  • CAPA Management
  • Data Analysis
  • Collaboration
  • Communication
  • Problem-Solving
  • Attention to Detail
  • Time Management

Responsibilities

  • Initiate, track, trend, lead, write, and close all investigations into internal failures and external customer complaints.
  • Drive completion of all corrective and preventive actions in a timely manner, collaborating with department-specific subject matter experts in root cause analysis.
  • Regularly conduct personnel interviews to learn the sequence of events in root cause investigations.
  • Analyze test data for chemical analyses as an inherent part of investigations.
  • Develop investigation SOPs, work instructions, and conduct associated training.
  • Ensure proper verification of effectiveness for all corrective and preventive actions.
  • Maintain the corrective and preventive actions database and analyze trends.
  • Work with all aspects of operations (Production, Packaging, Project Engineering, Quality Assurance, Quality Control, Maintenance) to ensure timely completion of CAPAs.
  • Ability to escalate actions cross-functionally when deadlines are approaching.
  • Participate in daily quality meetings to speak on the status of issues and bring awareness to or resolve any developing trends.
  • Participate in cross-functional meetings relating to failures.
  • Assist with creating weekly reports on all open investigations and ensure timely completion of investigations.
  • Assist with creating monthly reports on failure metrics and trends.

FAQs

Do we support remote work?

No, this is a fully on-site position in Saint Louis, Missouri.

What is the duration of the position?

This is a Contract-to-Hire position with a duration of 6 months.

What will be the primary responsibilities of the QA Investigator?

The primary responsibilities include initiating, tracking, trending, leading, writing, and closing investigations into internal failures and external customer complaints, as well as collaborating on root cause analysis and driving corrective and preventive actions.

What skills are required for this position?

Required hard skills include Root Cause Analysis, Chemical Analysis, SOP Development, CAPA Management, and Data Analysis. Soft skills required are Collaboration, Communication, Problem-Solving, Attention to Detail, and Time Management.

Will the QA Investigator be working alone or cross-functionally?

The QA Investigator will work cross-functionally with various teams including Production, Packaging, Project Engineering, Quality Assurance, Quality Control, and Maintenance.

What type of reports will the QA Investigator assist in creating?

The QA Investigator will assist with creating weekly reports on all open investigations and monthly reports on failure metrics and trends.

Is diversity and inclusion a priority for the company?

Yes, diversity and inclusion are embedded into the culture at Actalent through hiring diverse talent, maintaining an inclusive environment, and ensuring growth opportunities for all employees.

What is the work environment like?

The work environment involves desk-based responsibilities and will also include time spent on the production floor and in the quality lab while conducting investigations.

How does the company handle reasonable accommodation requests?

Requests for reasonable accommodations, such as adjustments in the job application or interviewing process due to a disability, can be made by emailing actalentaccommodation@actalentservices.com for other accommodation options.

What type of training will the QA Investigator be responsible for?

The QA Investigator will develop investigation SOPs, work instructions, and conduct associated training for personnel.

Actalent

An Engineering and Sciences Services Company | People to Possible

Human Resources
Industry
5001-10,000
Employees

Mission & Purpose

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference. Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research. Actalent is an operating company of Allegis Group, the global leader in talent solutions.