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QA Engineer (Pharmaceuticals)

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Actalent

13d ago

  • Job
    Full-time
    Senior Level
  • Science
  • Bridgeton

AI generated summary

  • You need a BS (or AS) degree and 5+ years in pharma, including lab and validation. Ideal candidates have QC data review or QA auditing experience and know validation protocols in manufacturing.
  • You will ensure QC data and documentation compliance, review validation protocols, approve investigations, and oversee quality processes with QC and project management teams.

Requirements

  • - BS Degree strongly preferred but can consider AS Degree.
  • - 5 Years of Pharma Industry experience including time in an analytical laboratory as well as validation procedures, tech transfer, process development, etc.
  • - 7 years + preferred
  • - Ideal experience with reviewing validation protocols within production/manufacturing processes.
  • - Must have either high level QC Data Review/Investigation experience or actual QA Auditing experience from a pharma company.

Responsibilities

  • - Will serve as Quality Assurance oversight for Quality Control (QC) data, documentation, and projects as well as Validation documentation and projects.
  • - Assist with these activities for third party manufacturers.
  • - Work 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.

FAQs

What is the main responsibility of the QA Engineer in this position?

The main responsibility of the QA Engineer is to provide Quality Assurance oversight for Quality Control data, documentation, and projects, as well as Validation documentation and projects, ensuring compliance and integration of quality into industrial operations.

What educational qualifications are preferred for this position?

A BS Degree is strongly preferred, but an AS Degree may also be considered.

How many years of experience in the pharmaceutical industry are required for this role?

A minimum of 5 years of experience in the pharmaceutical industry is required, with 7 years or more preferred.

What specific experience is ideal for candidates applying for this role?

Ideal candidates will have experience reviewing validation protocols within production/manufacturing processes, as well as either high-level QC Data Review/Investigation experience or actual QA Auditing experience from a pharmaceutical company.

Is experience in an analytical laboratory necessary for this position?

Yes, experience in an analytical laboratory is part of the required qualifications for this position.

What are some specific skills needed for this QA Engineer role?

Skills needed include knowledge of validation protocols, quality assurance, FDA compliance, GMP, and QC analysis.

Will the QA Engineer be involved in reviewing investigations?

Yes, the QA Engineer will review and approve OOS/OOT investigations for raw materials, intermediates, finished product testing, and other investigations related to projects or validation.

What is the work environment like at Actalent?

Actalent promotes a culture of diversity, equity, and inclusion, emphasizing an inclusive environment and opportunities for growth while continuously reflecting on and improving their practices.

Does Actalent provide accommodations for applicants with disabilities?

Yes, Actalent provides reasonable accommodations and applicants can request assistance with the application or interview process due to a disability by emailing actalentaccommodation@actalentservices.com.

Are there opportunities for career growth within Actalent?

Yes, Actalent emphasizes growth opportunities for its employees as part of its commitment to career development and engagement.

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.