Logo of Huzzle

Quality Investigator

image

Actalent

3mo ago

  • Job
    Full-time
    Senior Level
  • Science
    Healthcare
  • Greenville

AI generated summary

  • You need a bachelor's in microbiology or related field, 5+ years in pharma, investigation writing, 3+ years of environmental monitoring, and GMP experience.
  • You will conduct detailed investigations, ensure compliance with GMP and FDA regulations, analyze trends, determine root causes, and implement CAPAs while collaborating with operational teams.

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. 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 is the main responsibility of the Quality Investigator?

The main responsibility of the Quality Investigator is to perform thorough, detailed, and timely investigations, identifying root causes and implementing appropriate CAPAs (Corrective and Preventive Actions) in collaboration with operational leadership and quality representatives.

What educational background is required for this position?

A Bachelor's degree in microbiology or a related life science field is required for this position.

How many years of experience are necessary for this role?

A minimum of 5 years of experience in the pharmaceutical industry is required, with 3+ years of experience in environmental monitoring preferred.

Is experience with GMP regulations necessary?

Yes, experience with Good Manufacturing Practices (GMP) is necessary for this role.

What software or systems should the candidate be familiar with?

The candidate should have knowledge of Laboratory Information Management Systems (LIMS) or equivalent systems to identify trends and aberrant sample results.

Is prior experience in compiling trending data important for this role?

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

How does Actalent approach diversity, equity, and inclusion in its hiring practices?

Actalent promotes diversity and inclusion by hiring diverse talent, maintaining an inclusive environment, building a culture of care and recognition, and ensuring growth opportunities for all employees.

Can applicants with disabilities request accommodations during the application or interview process?

Yes, applicants with disabilities can request reasonable accommodations by emailing actalentaccommodation@actalentservices.com for assistance.

Is this position open to candidates of all backgrounds?

Yes, 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, genetic information, or any characteristic protected by law.

What type of work environment can a candidate expect?

A candidate can expect a collaborative work environment that involves working closely with operational leadership and staff within various Business Units.

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.