Logo of Huzzle

Quality Assurance Specialist

image

Actalent

12d ago

  • Job
    Full-time
    Junior Level
  • San Mateo

AI generated summary

  • You must document product quality complaints, perform investigations, ensure regulatory compliance, manage complaint samples, write deviations, and demonstrate critical thinking while collaborating cross-functionally.
  • You will handle product quality complaints, document investigations, ensure regulatory compliance, perform data analysis, assist in CAPA, and manage complaint samples from receipt to destruction.

Requirements

  • Receives product quality complaints for products.
  • Documents in Quality System for investigation of product quality complaints and triages safety events to the appropriate department.
  • Performs or provides support for product quality complaint investigations.
  • Performs a variety of activities to ensure compliance with applicable regulatory requirements.
  • Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Performs data analysis in support of product quality complaint investigations and quarterly trend analysis.
  • Assists lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.
  • Manages product complaint samples from receipt through destruction.
  • Normally receives general instruction on routine work, detailed instructions on new assignments.
  • Writing deviations on pharma/biotech product complaints (not reviewing or approving)
  • Writing all elements of product complaint deviations
  • Critical thinking skills to ask questions and dig in versus just taking things at face value
  • Working with cross-functional teams/CMOs (mostly via email, minimal meetings)

Responsibilities

  • Receives product quality complaints for products.
  • Documents in Quality System for investigation of product quality complaints and triages safety events to the appropriate department.
  • Performs or provides support for product quality complaint investigations.
  • Performs a variety of activities to ensure compliance with applicable regulatory requirements.
  • Maintains programs and processes to ensure high-quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
  • Performs data analysis in support of product quality complaint investigations and quarterly trend analysis.
  • Assists lead/coordinator with investigations and corrective and preventive action (CAPA) relating to manufactured products.
  • Manages product complaint samples from receipt through destruction.
  • Normally receives general instruction on routine work, detailed instructions on new assignments.

FAQs

What is the job title for this position?

The job title is Quality Assurance Specialist.

What are the primary responsibilities of a Quality Assurance Specialist?

The primary responsibilities include receiving and documenting product quality complaints, providing support for investigations, ensuring compliance with regulatory requirements, maintaining GMP and GLP processes, performing data analysis, and managing product complaint samples.

What are the hard skills required for this position?

The hard skills required include writing deviations on pharma/biotech product complaints, writing all elements of product complaint deviations, and critical thinking skills to analyze information thoroughly.

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

Yes, the soft skills important for this role include the ability to work with cross-functional teams and Contract Manufacturing Organizations (CMOs), primarily through email with minimal meetings.

Is this a full-time or part-time position?

This is a contract position with a duration of 1 year.

What is the work environment for this position?

The work environment is hybrid; employees work on-site in Foster City, California, on Tuesdays, Wednesdays, and Thursdays, while working from home on Mondays and Fridays.

Is this position open to diverse applicants?

Yes, the company is an equal opportunity employer and encourages applications from all individuals, regardless of race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any characteristic protected by law.

What is the company’s stance on diversity and inclusion?

The company values diversity, equity, and inclusion, integrating these principles into their culture through diverse hiring, maintaining an inclusive environment, recognizing and engaging employees, and ensuring growth opportunities.

How should I request accommodations during the application process?

If you need to request a reasonable accommodation due to a disability, you can email actalentaccommodation@actalentservices.com for other accommodation options.

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.