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QA Validation

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Actalent

3mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Healthcare
  • Philadelphia

AI generated summary

  • You must identify risks, develop mitigation strategies, ensure cGMP compliance, create documentation, provide quality guidance, and collaborate cross-functionally on complex quality issues.
  • You will identify risks, support cGMP compliance, maintain documentation, guide cross-functional teams, and address quality issues through investigations and corrective actions.

Requirements

  • Identifying risk, developing mitigation strategies, alternative solutions, resolving issues, in collaboration with cross-functional groups such as Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation.
  • Supporting cGMP quality improvement efforts local site in Philadelphia, PA, and in remote facilities such as their other site in Philadelphia, PA, and the Tampa Labs (Tampa Bay, FL).
  • Creating and maintaining company documentation, such as quality manuals, validation protocols, Standard Operating Procedures, and Work Instructions.
  • Applying good manufacturing practice and observing that it is being adhered to.
  • Represent Quality on cross-functional teams to complete projects, address quality issues, and implement quality system improvements.
  • Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes, and disposition of discrepant material.
  • Quality Engineering oversight
  • GMP equipment design and installation
  • System lifecycle management
  • Quality policy formulation
  • Audit and regulatory compliance support
  • Documentation creation and maintenance
  • Root cause analysis investigations
  • Risk identification
  • Mitigation strategy development
  • Cross-functional collaboration
  • Technical guidance
  • Quality issue resolution

Responsibilities

  • Identifying risk, developing mitigation strategies, alternative solutions, resolving issues, in collaboration with cross-functional groups such as Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation.
  • Supporting cGMP quality improvement efforts local site in Philadelphia, PA, and in remote facilities such as their other site in Philadelphia, PA, and the Tampa Labs (Tampa Bay, FL).
  • Creating and maintaining company documentation, such as quality manuals, validation protocols, Standard Operating Procedures, and Work Instructions.
  • Applying good manufacturing practice and observing that it is being adhered to.
  • Represent Quality on cross-functional teams to complete projects, address quality issues, and implement quality system improvements.
  • Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity including root cause analysis investigations, addressing purchased component quality issues, complaint product evaluations, development and implementation of corrective actions, initiation and approval of product/process changes, and disposition of discrepant material.

FAQs

What are the working hours for the QA Validation position?

The working hours are from 3pm to 11:30pm, Monday through Friday, with one remote day per week.

Is this position fully remote?

No, this is a fully on-site position in Philadelphia, Pennsylvania, with an option for one day of remote work per week.

What type of work environment can I expect in this role?

This is primarily an office-based role, with 80% of the work done in the office.

What key responsibilities will the QA Validation Associate have?

Key responsibilities include providing Quality Engineering oversight, supporting GMP equipment design and installation, ensuring compliance with quality policies, conducting audits, and maintaining documentation.

What skills are essential for this position?

Hard skills include Quality Engineering oversight, GMP equipment design, system lifecycle management, and documentation maintenance. Soft skills include risk identification, cross-functional collaboration, and quality issue resolution.

What types of teams will the QA Validation Associate collaborate with?

The QA Validation Associate will collaborate with cross-functional groups such as Manufacturing, Quality Control, IT, Supply Chain, Engineering, and Validation.

Is this position permanent?

Yes, this is a permanent position.

What does Actalent value in its workplace culture?

Actalent values diversity, equity, and inclusion, focusing on hiring diverse talent, maintaining an inclusive environment, and ensuring growth opportunities for its people.

Can I request accommodations during the application process?

Yes, if you need a reasonable accommodation due to a disability, you can email actalentaccommodation@actalentservices.com for assistance.

What kind of training does the QA Validation Associate provide?

The QA Validation Associate conducts training on quality concepts and tools as part of their responsibilities.

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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.