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Quality Investigator

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Actalent

7d ago

  • Job
    Full-time
    Senior Level
  • Research & Development
  • Raleigh

AI generated summary

  • You need a Bachelor’s in microbiology or related life science, 5+ years in pharma, investigation writing, 3+ years in environmental monitoring, and GMP experience.
  • You will conduct detailed investigations, collaborate with operational teams, analyze trends, ensure compliance with GMP/FDA regulations, and implement corrective actions based on findings.

Requirements

  • Bachelor's degree in microbiology or a related life science field
  • 5+ years of experience in the pharmaceutical industry
  • Experience with writing investigations
  • Environmental monitoring experience in the pharmaceutical industry (3+ years ideal)
  • GMP experience

Responsibilities

  • The Quality Investigator will be responsible for performing thorough, detailed, and timely investigations.
  • The individual will develop collaborative relationships with the operational leadership and staff in each of the Business Units and the appropriate Quality representatives to facilitate investigations using continuous improvement techniques, identify root cause, and implement appropriate CAPAs.
  • The investigator needs to have experience in Environmental Monitoring and a working knowledge of the appropriate GMP and FDA regulations.
  • The individual will be expected to have knowledge of LIMS (or equivalent system) and be able to identify trends and aberrant sample results.
  • Prior experience compiling trending data is a plus.
  • The individual in this role will also be required to complete investigations in a timely manner, make recommendations on the disposition of materials from investigational data, determine root cause, and implement appropriate CAPAs.

FAQs

What qualifications are required for the Quality Investigator position?

A Bachelor's degree in microbiology or a related life science field is required, along with 5+ years of experience in the pharmaceutical industry.

Is experience in Environmental Monitoring necessary for this role?

Yes, at least 3 years of experience in Environmental Monitoring within the pharmaceutical industry is ideal.

What specific skills are required for the Quality Investigator?

The candidate should have experience with writing investigations, GMP experience, and a working knowledge of LIMS or equivalent systems.

What is the main responsibility of the Quality Investigator?

The main responsibility is to perform thorough, detailed, and timely investigations, facilitate continuous improvement techniques, identify root causes, and implement appropriate CAPAs.

Is experience with trending data compilation a plus?

Yes, prior experience compiling trending data is considered a plus for this position.

How does Actalent ensure diversity and inclusion in the workplace?

Actalent ensures diversity and inclusion through hiring diverse talent, maintaining an inclusive environment, building a culture of care, and providing growth opportunities for all employees.

What is the job location for the Quality Investigator position?

The job location details are not specified in the job description, so it's best to inquire with Actalent directly.

How does Actalent approach equal opportunity employment?

Actalent is an equal opportunity employer and considers all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, or any characteristic protected by law.

What should I do if I need accommodations during the application process?

If you require accommodations due to a disability, you can email actalentaccommodation@actalentservices.com for assistance with the application or interview process.

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.