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Quality Assurance Specialist

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Actalent

3mo ago

  • Job
    Full-time
    Mid & Senior Level
  • Camarillo

AI generated summary

  • You need experience with global pharma regulations, ISO 9001, quality systems, and auditing. Strong organization, math, communication skills, integrity, teamwork, and a drive for quality are essential.
  • You will manage the Quality System, handle nonconforming products, oversee document control, conduct inspections, perform audits, and implement quality system improvements.

Requirements

  • Understanding of global pharmaceutical product regulations
  • Experience with ISO 9001 and/or :2003 and 21 CFR Parts 210 and 211 and/or Part 820
  • Quality System management including corrective actions, change control, quality audits, and validation of manufacturing processes
  • Experience in a pharmaceutical or medical device environment
  • Solid organizational and planning skills
  • Good general mathematical skills
  • General computer skills
  • Effective verbal and written communication
  • Good interpersonal skills interdepartmentally and with external vendors and contractors
  • Ability to work effectively and efficiently in a team environment
  • Integrity and trust
  • Strong work ethic
  • Sound judgment
  • Pragmatism
  • Courage
  • Passion to innovate and drive for solutions
  • Personal accountability for results and integrity
  • Eagerness to learn and continuously improve
  • Uncompromising dedication to quality

Responsibilities

  • Collaborate with stakeholders to manage the Quality System.
  • Maintain, recommend, and implement changes to the existing quality system regarding nonconforming products, corrective/preventive actions, document control, quality control inspections and product release, internal audits, validations, and equipment calibration and maintenance programs.

FAQs

Is this position fully on-site or remote?

This is a fully on-site position in Camarillo, California.

What are the key hard skills required for this role?

Key hard skills required include understanding global pharmaceutical product regulations, experience with ISO 9001 and/or 21 CFR Parts 210 and 211 and/or Part 820, and quality system management including corrective actions and quality audits.

What soft skills are essential for a Quality Assurance Specialist?

Essential soft skills include effective verbal and written communication, good interpersonal skills, integrity and trust, and a strong work ethic.

What is the primary focus of this position?

The primary focus of this position is managing the Quality System with an emphasis on complaints and investigations.

Does Actalent promote diversity and inclusion in their hiring process?

Yes, Actalent embeds diversity, equity, and inclusion into their culture through hiring diverse talent and maintaining an inclusive environment.

Are there opportunities for career growth within Actalent?

Yes, Actalent emphasizes ensuring growth opportunities for their people as part of their culture.

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

The work environment involves collaborating with various stakeholders, conducting audits, managing change control programs, and participating in equipment validation and maintenance in a pharmaceutical or medical device environment.

Can I request reasonable accommodation during the application process?

Yes, you may request a reasonable accommodation for the job application or interviewing process due to a disability by emailing actalentaccommodation@actalentservices.com.

Which industries does Actalent primarily serve?

Actalent primarily serves the engineering and sciences sectors, including pharmaceutical and medical device environments.

What is the expected work ethic from candidates applying for this position?

Candidates are expected to have a strong work ethic, sound judgment, and a dedication to quality and personal accountability for results and integrity.

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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.