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QA Validation

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Actalent

3mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Philadelphia

AI generated summary

  • You must have experience in quality engineering, GMP equipment, lifecycle management, compliance support, documentation, root cause analysis, risk identification, and cross-functional collaboration.
  • You will oversee quality engineering for cGMP cell therapy manufacturing, support audits, develop policies, create documentation, and collaborate with teams to resolve quality issues and improve processes.

Requirements

  • 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

  • The QA Validation Associate will provide Quality Engineering oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Quality Assurance Engineering Specialist will be responsible for supporting the design, installation, and evaluation of GMP equipment, system utilities, components, products, and computer systems while ensuring they are fully operational, effective, and free from defects during the entire system lifecycle. Further support the formulation of quality policies, procedures as well as conducting training on quality concepts/tools. In addition, the Quality Assurance Engineering Specialist will support audit and submission activities for regulatory compliance. 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 is the job title for this position?

The job title for this position is QA Validation Associate.

Where is this position located?

This position is located in Philadelphia, Pennsylvania.

What type of work environment is expected for this role?

This is primarily an office-based role, with 80% of the work done in the office and an option for 1 day of remote work.

What type of documentation will the QA Validation Associate be responsible for?

The QA Validation Associate will be responsible for creating and maintaining company documentation such as quality manuals, validation protocols, Standard Operating Procedures, and Work Instructions.

What are the primary responsibilities of the QA Validation Associate?

The primary responsibilities include providing Quality Engineering oversight, supporting design and installation of GMP equipment, ensuring compliance with quality standards, conducting training on quality concepts, supporting audits and submissions, and collaborating with cross-functional teams.

What skills are required for this position?

Required skills include Quality Engineering oversight, GMP equipment design and installation, system lifecycle management, audit and regulatory compliance support, and documentation creation and maintenance.

Are there any specific soft skills needed for this role?

Yes, necessary soft skills include risk identification, mitigation strategy development, cross-functional collaboration, technical guidance, and quality issue resolution.

Is this a permanent position?

Yes, this is a permanent position.

What does the company, Actalent, focus on?

Actalent focuses on providing engineering and sciences services and talent solutions to help companies advance their engineering and science initiatives.

Does Actalent have a commitment to diversity and inclusion?

Yes, Actalent is committed to diversity and inclusion, and these values are embedded into their culture and hiring practices.

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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.