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Quality Assurance Specialist

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Actalent

3mo ago

  • Job
    Full-time
    Junior, Mid & Senior Level
  • Camarillo

AI generated summary

  • You should understand global pharma regulations, have ISO 9001/21 CFR experience, and be skilled in quality systems, audits, and manufacturing validation. Strong communication and teamwork are essential.
  • You will manage the quality system, conduct audits, implement changes for nonconformance, and ensure effective teamwork in compliance with regulations in a pharmaceutical or medical device setting.

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.
  • Conducting audits, managing change control programs, and participating in equipment validation and maintenance.
  • The role requires effective teamwork and communication in a pharmaceutical or medical device environment.

FAQs

Is this position remote or on-site?

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

What is the main focus of the Quality Specialist role?

The main focus is on managing the Quality System with an emphasis on complaints and investigations, including nonconforming products and corrective/preventive actions.

What regulatory knowledge is required for this position?

Candidates should have an understanding of global pharmaceutical product regulations and experience with ISO 9001, 21 CFR Parts 210 and 211, and/or Part 820.

What experience is preferred for applicants?

Experience in a pharmaceutical or medical device environment is preferred, along with familiarity in quality system management, corrective actions, and quality audits.

What kind of skills are emphasized in the job description?

Both hard skills (like knowledge of regulations and quality systems) and soft skills (such as effective communication, teamwork, and a strong work ethic) are emphasized.

Are there opportunities for professional growth within the company?

Yes, Actalent values continuous improvement and learning, providing growth opportunities for employees.

What is the company's stance on diversity, equity, and inclusion?

Actalent promotes diversity and inclusion as integral to its culture, with initiatives aimed at hiring diverse talent and creating an inclusive environment.

How does the company handle reasonable accommodation requests?

Employees or candidates can request reasonable accommodations for the job application or interviewing process due to a disability by emailing actalentaccommodation@actalentservices.com.

Are there specific mathematical skills required for the role?

Yes, good general mathematical skills are necessary for this position.

What qualities does Actalent look for in a candidate's character?

Actalent seeks candidates with integrity, sound judgment, personal accountability, and a dedication to quality and innovation.

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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.