QA Specialist

Location: USA : MadisonState: WisconsinCountry: USAOur purpose points the wayIn 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 SpecialistThe 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 ByHelping 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 HoldAssociates 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, 2024At 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.comNot the right fit for you?Even if this job isn't the right fit for you, perhaps you know someone who might find it interesting. If so, please feel free to share the job link and encourage them to apply. Thank you for your referral! Please check out our other open positions. The right fit for you could just be a few clicks away.