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QA Engineer (Pharmaceuticals)

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Actalent

3mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Bridgeton

AI generated summary

  • You must have technical validation understanding, analytical data review skills, chemistry or lab experience, and contract lab or pharma manufacturing experience. Work independently and solve problems effectively.
  • You will oversee QC data, review and approve validation protocols, SOPs, investigations, and documents, ensuring compliance and quality in operations and support Annual Product Review activities.

Requirements

  • Understanding of validations from a technical standpoint
  • Ability to review analytical data
  • Chemistry or lab experience
  • Experience in a contract lab setting or pharma manufacturing environment
  • Ability to work independently and with guidance as needed
  • Conservative yet problem-solving approach

Responsibilities

  • Will serve as Quality Assurance oversight for Quality Control (QC) data, documentation, and projects as well as Validation documentation and projects. The position will also assist with these activities for third party manufacturers. This position works directly with QC, Validation, and Project management to integrate Quality into industrial operations.
  • Serve as QA reviewer and approver of QC release, stability and raw material data
  • Serve as QA reviewer and approver of site validation protocols including production equipment, computer systems, laboratory equipment and methods
  • Review SOPs for accuracy and compliance; draft revisions for updates as necessary
  • Review and approve OOS/OOT investigations for raw materials, intermediates and finished product testing
  • Review and approve investigations as it related to the execution of the project or validation
  • Provide QA reviews and approvals of QC and/or Validation procedures, methods, change controls, CAPAs, deviations, and other documents, as necessary
  • Support Annual Product Review responsibilities for the site

FAQs

Is this position fully remote?

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

What percentage of my workload will be focused on QA activities?

80% of the workload will be focused on QA over QC, with the other 20% split between QA over Validation and Annual Product Reviews.

What kind of experience is required for this position?

Candidates should have experience in a contract lab setting or a pharmaceutical manufacturing environment, and a background in chemistry or lab experience is preferred.

What are the main responsibilities of this QA Engineer role?

Key responsibilities include serving as QA reviewer for QC release data, validation protocols, SOPs, and investigations, as well as supporting Annual Product Review responsibilities.

What educational background is preferred for this role?

A background in chemistry or related fields, along with experience in validation processes, is preferred.

How does Actalent approach Diversity, Equity & Inclusion?

Actalent embeds DE&I into its culture through diverse hiring, maintaining an inclusive environment, building a culture of care and engagement, and ensuring growth opportunities for all employees.

Will I work independently and collaboratively in this role?

Yes, the position requires the ability to work independently while also collaborating with QC, Validation, and Project Management teams as needed.

Is there an opportunity for career growth in this position?

Yes, Actalent is committed to providing growth opportunities for its employees.

Can I request accommodations during the application process?

Yes, candidates can request reasonable accommodations during the application or interview process by emailing actalentaccommodation@actalentservices.com.

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.