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Quality Assurance Specialist

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Actalent

6d ago

  • Job
    Full-time
    Mid & Senior Level
  • Camarillo

AI generated summary

  • You need knowledge of pharma regulations, ISO 9001, quality system management, strong math skills, good communication, teamwork, integrity, and a passion for quality and continuous improvement.
  • You will manage the Quality System, oversee audits, handle nonconformances, implement changes, and ensure compliance through inspections, validations, and equipment maintenance.

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.
  • Conduct audits, manage change control programs, and participate in equipment validation and maintenance.

FAQs

Is this position fully remote?

No, this is a fully on-site position located in Camarillo, California.

What are the primary responsibilities of a Quality Assurance Specialist in this role?

The primary responsibilities include collaborating with stakeholders to manage the Quality System, implementing changes related to nonconforming products, corrective/preventive actions, document control, quality control inspections, internal audits, validations, and equipment calibration and maintenance programs.

What hard skills are required for this job?

Required hard skills include understanding of global pharmaceutical product regulations, experience with ISO 9001 and 21 CFR Parts 210, 211, and 820, quality system management, and experience in a pharmaceutical or medical device environment, among others.

Are there specific soft skills that are important for this position?

Yes, important soft skills include effective verbal and written communication, good interpersonal skills, the ability to work effectively in a team environment, and a strong work ethic, among others.

What type of company is Actalent?

Actalent is a global leader in engineering and sciences services and talent solutions, helping companies advance their engineering and science initiatives through access to specialized experts.

Does Actalent promote diversity and inclusion?

Yes, Actalent embeds diversity, equity, and inclusion into its culture through hiring diverse talent, maintaining an inclusive environment, and ensuring growth opportunities for all employees.

What qualifications are necessary to apply for this role?

Candidates should have a good understanding of global pharmaceutical regulations, experience in quality system management, and experience in a pharmaceutical or medical device environment.

How does Actalent handle accommodations for disabilities?

If a candidate requires a reasonable accommodation during the job application or interviewing process due to a disability, they can email actalentaccommodation@actalentservices.com for assistance.

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.