QA Specialist

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Madison, WI
3-5 Years Experience
Biotech
The Role

Location: USA : Madison

State: Wisconsin

Country: USA

Our purpose points the way

In Novonesis, we know that solutions rooted in biology can help solve humanity's biggest challenges. Since we began more than a century ago, this has been our guide. It's how we've gotten so far. And it's how we'll impact the future. Now, more than ever, the world needs change. And with biosolutions, the possibilities for transformation are endless.

We're here to better our world with biology.

Join us as our new Quality Assurance Specialist

The Quality Assurance Specialist provides technical and professional assistance to various functions within the organization to support the achievement of quality, safety, sales and production goals and provides ongoing maintenance and continuous improvement of the Quality Management System.

In this role you'll make an impact by:

  • Helping to participate in and lead facility quality management systems, including document control, CAPA, deviations, qualifications, validations, audits, and food safety preventive controls per FSMA requirements.
  • Assisting with BPR, records review, and generating product Certificate of Analyses.
  • Managing the customer complaint process and coordinating supplier and contract laboratory management activities.
  • Supporting all GMP departments by collaborating with the teams in order to write Standard Operating Procedures, Work Instructions, and forms, as needed.
  • Identifying, prioritizing, communicating, and resolving supplier quality issues by working closely with the procurement department and providing trending analysis on supplier quality and performance metrics.
  • Assisting with new process design and validation, performing internal quality/process audits, and developing process monitoring systems in accordance with food safety plans.
  • Working with all functional areas to resolve quality issues, assure compliance with regulations, company standards, and customer requirements, and facilitating continuous improvement and learning across all functional areas.
  • Overseeing the batch record issuance process, maintaining and updating quality-related spreadsheets and trackers, performing other duties as assigned, and collecting and trending off-line data for quality and process performance data.

To succeed you must hold:

  • Associates degree in a related field; or 4 years related experience and/or training in manufacturing environment; or equivalent combination of education and experience.
  • Quality Assurance experience with a focus on quality systems in an FDA-regulated manufacturing environment, preferably in food, dietary supplements or pharmaceuticals.
  • Possesses strong working knowledge in GMP in FDA regulated industry, preferably food or dietary supplement manufacturing, and a fundamental understanding of quality systems and their development, documentation, implementation, and improvement.
  • Holds ASQ Quality Auditor certification (preferred) and demonstrates skill in audit planning, techniques, execution, reporting results, and follow-up.
  • Proficient with problem-solving and quality improvement tools and techniques, and able to plan, control, and assure product and process quality in accordance with quality principles.
  • Exhibits excellent communication, organizational, planning, problem-solving, and follow-up skills, with the ability to work effectively as a team player in a diverse work group.
  • Self-motivated and able to work unsupervised, with strong written and verbal communication skills, and a strong attention to detail.
  • Displays enthusiastic, cooperative, and positive behavior/attitude, with occasional travel required, and strong computer skills including proficiency in Microsoft Word, Excel, Power Point, and Visio. Experience with EQMS and ERP systems is a plus.

Could our purpose be yours? Then apply today!

Application deadline: July 31, 2024

At Novonesis we commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We recommend you not to attach a cover letter to your application. Instead, please include a few sentences in your resume/CV about why you are applying. To ensure a fair recruitment process, please refrain from adding a photo in your resume/CV.

Novonesis is committed to creating a diverse environment and is proud to be an equal opportunity and affirmative action employer. All employment decisions are based on business needs without regard to race, color, ethnicity, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, disability, or veteran status.

Want to learn more?

Learn more about Novonesis, our purpose, and your career opportunities at novonesis.com

Not the right fit for you?

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The Company
HQ: Milwaukee, WI
3,435 Employees
On-site Workplace
Year Founded: 1874

What We Do

We are a leading, global bioscience company that develops natural ingredient solutions for the food, nutritional, pharmaceutical and agricultural industries. Our natural solutions play a key role in creating a food system that is resilient and prepared to feed a growing population while also minimizing its adverse climate impact – ensuring greater sustainability from farm to fork.

Our product innovation is based on almost 40,000 microbial strains – we like to refer to them as ‘good bacteria’. With the offset in our microbial platform, we are uniquely positioned to address some of society’s most pressing challenges such as climate change, food waste, global health and the overuse of antibiotics and pesticides.

Developing sustainable solutions is an integral part of Chr. Hansen’s quest to grow a better world naturally. The UN Sustainable Development Goals are an integrated part of our corporate strategy, focusing on goal 2, 3 and 12 related to zero hunger, good health and responsible consumption and production. In fact, 81% of our revenue directly supports these goals. In a commitment to curb climate change and limit the global temperature rise, Chr. Hansen has joined the Science Based Targets initiative to limit the global temperature rise, and commits to set ambitious carbon emission reduction targets.

We are humbled and proud that Chr. Hansen several times has been recognized as a global sustainability leader. For five consecutive years (2018 – 2022) Chr. Hansen has been listed on Corporate Knights’ list of the Global 100 Most Sustainable Corporations. The inclusion on the list was cemented in 2019, 2020 and 2022 when we were ranked respectively no. 1, 2 and 2.

We have been delivering value to our partners – and, ultimately, end consumers worldwide – for over 145 years. We are proud that more than one billion people consume products containing our natural ingredients every day.

Let’s grow a better world. Naturally.

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