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Quality Assurance Specialist

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Actalent

3mo ago

  • Job
    Full-time
    Mid Level
  • Maple Grove

AI generated summary

  • You need 3+ years in Quality Management Systems, CAPA/GMP experience, strong attention to detail, problem-solving skills, and the ability to coordinate Quality Programs and support audits.
  • You will manage document issuance, batch reviews, product complaints, and quality systems, ensuring compliance with cGMPs while supporting continuous improvement and regulatory audits.

Requirements

  • Experience working within Quality Management system - 3+ years
  • Quality Management System - 3+ years
  • CAPA/GMP experience
  • Attention to detail
  • Problem-solving skills
  • Ability to engage with internal and external organizations
  • Coordination and maintenance of Quality Programs
  • Support for regulatory inspections and GMP audits

Responsibilities

  • Looking for a Quality Assurance specialist to support day-to-day operations for the commercial assurance team.
  • This individual will handle document issuance and batch review for commercial testing and manufacturing.
  • They will manage product complaints, project activities, and quality systems related to commercial manufacturing.
  • Responsibilities include performing document issuance for testing and manufacturing, assuring appropriate reconciliation of documentation, and conducting thorough documentation reviews, including non-conformance events/deviations, data analysis, and executed batch records, using working knowledge of cGMPs and internal procedures and controls.
  • The specialist will provide final product disposition determination, aid in the coordination and maintenance of Quality Programs such as Change Management, Non-Conformances, CAPA, Complaints, Annual Product Reviews, and Management Reviews.
  • They will also maintain expertise in one or more QA disciplines to perform analysis and draw conclusions, identify and resolve quality issues in consultation with management and other departments, engage with internal and external organizations to meet batch release timelines, provide support for regulatory inspections and GMP audits, participate in planning and prioritization for resolving quality and compliance issues, author/review procedures within the Blood Product Quality Management System, and provide metrics and data-driven solutions to reduce the cost of quality and improve monitoring system efficiency for blood products.

FAQs

What are the primary responsibilities of the Quality Assurance Specialist?

The primary responsibilities include handling document issuance and batch review for commercial testing and manufacturing, managing product complaints, conducting thorough documentation reviews, providing final product disposition determination, and supporting the coordination of various quality programs.

What qualifications are required for this position?

Candidates should have a minimum of 3 years of experience working within a Quality Management System, with specific experience in CAPA and GMP processes.

What soft skills are important for success in this role?

Important soft skills include attention to detail, problem-solving skills, the ability to engage with internal and external organizations, and experience in coordinating and maintaining Quality Programs.

Will the Quality Assurance Specialist be involved in regulatory inspections?

Yes, the specialist will provide support for regulatory inspections and GMP audits.

What qualifications are necessary regarding knowledge of regulations?

Candidates should have a working knowledge of cGMPs (current Good Manufacturing Practices) and internal procedures and controls.

Is this position open to diverse candidates?

Yes, the company is committed to diversity and inclusion and welcomes applications from candidates of all backgrounds.

How can I request accommodations during the application process?

You can request accommodations by emailing actalentaccommodation@actalentservices.com for options available.

Does the role require collaboration with other departments?

Yes, the role involves identifying and resolving quality issues in consultation with management and other departments.

What type of documentation will the specialist be responsible for reviewing?

The specialist will review documentation related to non-conformance events/deviations, data analysis, and executed batch records.

Is there a specific focus on blood products in this role?

Yes, the position emphasizes providing metrics and data-driven solutions to improve monitoring systems specifically for blood products.

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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.