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Quality Assurance Supervisor

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Actalent

14d ago

  • Job
    Full-time
    Senior Level
  • Healthcare
  • Verona

AI generated summary

  • You need a B.S. in a life science with 7 years GMP experience or a Master's with 5 years, 2 years supervisory experience, and a desire for long-term QA growth.
  • You will ensure product compliance, manage non-conformance, assess product releases, write food safety plans, provide training, edit SOPs, oversee shipments, and supervise a QA team.

Requirements

  • B.S. chemistry, biochemistry, biology or related life science field with 7 years of GMP experience in the pharmaceutical/biotech industry OR Masters with 5 years of GMP experience
  • 2 years of supervisory experience
  • Software validation experience is a plus
  • Experience with making decisions on releasing of raw materials and finished products (QC writes OOS but QA decides if they agree)
  • QC lab/chemistry experience is a plus (equipment review experience)
  • PCQI certified- most preferred- but they can provide certification (8-16 hour training)
  • SQF certified- nice to have
  • Candidate who wants to be in QA long term- future opportunities within the next 5 years (people retiring)
  • Experience within contract manufacturing companies. A lot of moving parts compared to contract labs.
  • Culture fit: Patient, self-motivated, positive, mentor other employees

Responsibilities

  • Ensure compliance and manage non-conformance issues related to raw materials and finished products.
  • Focus on assessing the release of products and addressing any deviations by collaborating with production and QC teams.
  • Write food safety plans for a multi-product facility that includes pharmaceutical, dietary, and food products.
  • Provide PCQI training and support the Master Control system, eventually becoming an expert.
  • Edit and approve SOPs.
  • Oversee shipment releases.
  • Supervise a growing QA team.

FAQs

What is the job title for this position?

The job title is Quality Assurance Supervisor.

What are the main responsibilities of the Quality Assurance Supervisor?

Main responsibilities include ensuring compliance, managing non-conformance issues, assessing the release of products, writing food safety plans, providing PCQI training, editing and approving SOPs, overseeing shipment releases, and supervising the QA team.

What qualifications are required for the Quality Assurance Supervisor role?

A B.S. in chemistry, biochemistry, biology, or a related life science field with 7 years of GMP experience in the pharmaceutical/biotech industry, or a Master's with 5 years of GMP experience, along with 2 years of supervisory experience.

Is software validation experience necessary for this position?

No, software validation experience is a plus but not a requirement.

Is PCQI certification mandatory?

PCQI certification is preferred, but the company can provide the necessary training for certification.

Where is this position located?

This is a fully on-site position located in Verona, Wisconsin.

What does the immediate team structure look like?

The immediate team includes the Director of QA, QA Manager, QA personnel in production, and a QA Specialist.

Is this a permanent position?

Yes, this is a permanent position.

Is experience within contract manufacturing companies preferred?

Yes, experience in contract manufacturing is preferred, as it involves managing a lot of moving parts.

How does Actalent support diversity, equity, and inclusion?

Actalent supports diversity, equity, and inclusion through hiring diverse talent, maintaining an inclusive environment, building a culture of care, and ensuring growth opportunities for all employees.

What type of work environment can be expected in this role?

The work environment includes collaboration with a team of QA professionals and management, focusing on quality assurance and compliance in a multi-product facility.

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.