Biotechnology Project Manager Jobs in Delafield, WI

Quality Assurance Specialist – Food Safety and Quality Systems

Location: Franksville, Wisconsin
Reports To: Director of Quality
Employment Type: Full-Time, Exempt

Help shape the systems that ensure the safety, quality, and regulatory compliance of innovative probiotic cultures, food ingredients, and dietary supplements.

At CSL USA, we believe our future is built on the talent, dedication, and passion of our people. If you're looking for an opportunity to make a meaningful impact, grow professionally, and help strengthen world-class Food Safety and Quality Systems, we'd love to meet you.

Our Approach to Quality

At CSL USA, we believe Quality is more than compliance—it's a strategic business partner. Our Quality team works collaboratively across the organization to serve our customers by bringing high-quality products to market, supporting innovation, and continually strengthening our Quality and Food Safety Systems. We value professionals who combine strong Quality Assurance expertise with systems-thinking, a practical, customer-focused mindset, a sense of urgency, and a passion for continuous improvement while maintaining regulatory compliance.

How You'll Make an Impact

As a member of our Quality team, you'll serve our customers by delivering safe, high-quality products, accurate technical documentation, and exceptional service. You'll have the opportunity to lead and support key Food Safety and Quality programs while collaborating closely with colleagues across CSL USA and Sacco System worldwide to strengthen our Quality and Food Safety Systems, support innovation, and drive continuous improvement.

Your responsibilities will include:

Lead Through Collaboration

1. Partner closely with Production, Quality Control, Sales & Customer Service, and Operations (Planning, Procurement, Supply Chain) and other departments to solve problems, strengthen quality systems, improve operational performance, and deliver exceptional service to our customers.
2. Collaborate with Quality and technical colleagues across Sacco System worldwide to leverage quality systems, share best practices, and contribute to quality initiatives.
3. Plan and conduct supplier audits and contract manufacturer audits while fostering strong partnerships focused on quality, food safety, and continuous improvement.
4. Develop and deliver GMP, GDP, Food Safety, and job-specific training programs to support strengthening organizational capability and quality culture.

Serve Our Customers

1. Prepare accurate, timely customer-facing technical documentation, including product specifications, technical questionnaires, quality agreements, technical and quality letters, and other customer communications.
2. Serve as a key Quality partner in new product commercialization projects, collaborating across functions to help bring innovative probiotic, food ingredient, and dietary supplement products to market on time while maintaining the highest standards of quality, food safety, and regulatory compliance.
3. Serve as a Quality representative during customer audits while building trusted relationships through technical expertise, responsiveness, and professionalism.

Strengthen Operational Excellence and Quality Systems

1. Lead, strengthen, maintain assigned elements of the Food Safety Management System (FSMS) and Quality Management System (QMS).
2. Lead or participate in HACCP and Food Safety Team activities, including hazard analysis, Food Defense, Food Fraud Prevention, Traceability, Mock Recall, and verification activities.
3. Support compliance with FSSC 22000, 21 CFR Part 117, 21 CFR Part 111, Kosher, Halal, and other applicable regulatory or certification requirements.
4. Coordinate supplier qualification, approval, and ongoing performance monitoring.
5. Review production and quality records to support timely product release and ensure documentation accuracy.

Drive Continuous Improvement

1. Lead investigations involving deviations, complaints, CAPAs, and root cause analysis while partnering with cross-functional teams to implement effective corrective and preventive actions.
2. Develop, review, and continuously improve SOPs, specifications, forms, procedures, and other controlled Quality System documentation.
3. Support monitoring, analyzing, and presenting of Quality performance metrics
4. Help shape the future of our Quality Management System by identifying opportunities to simplify processes, strengthen systems, and support the company's pursuit of additional third-party certifications.

Required Qualifications

• Bachelor's degree in Food Science, Microbiology, Biology, Chemistry, Biochemistry, or another relevant scientific discipline.
• Progressive experience in Quality Assurance within the food, dietary supplement, pharmaceutical, biotechnology, biomanufacturing, medical device, or another regulated manufacturing industry.
• Working knowledge of Good Manufacturing Practices (GMPs) and quality systems.
• Excellent written and verbal communication skills with the ability to prepare clear technical documentation and communicate effectively with employees, customers, auditors, suppliers, and regulatory agencies.
• Strong organizational, analytical, and problem-solving skills with excellent attention to detail.
• Ability to manage multiple priorities while maintaining a high standard of quality and accuracy.

Preferred Qualifications

• Academic background and/or practical experience in microbiology is highly desirable.
• Experience developing, implementing, or maintaining HACCP-based Food Safety Management Systems; HACCP certification strongly preferred.
• Preventive Controls Qualified Individual (PCQI) certificate or training preferred.
• Experience with FSSC 22000 or another GFSI-recognized Food Safety Management System (e.g., FSSC 22000, SQF, BRCGS, or IFS); Lead Auditor or Internal Auditor training is a plus.
• Experience with 21 CFR Part 117 and/or 21 CFR Part 111.
• Experience leading or participating in internal, supplier, customer, and contract manufacturer audits.
• Experience with supplier qualification, supplier quality management, and risk assessment.
• Experience leading investigations, root cause analysis, CAPA, and continuous improvement initiatives.
• Experience with ERP, LIMS, electronic Quality Management Systems (eQMS), or document control systems.
• Advanced proficiency with Microsoft Office, including Word, Excel, Visio.
• Demonstrated commitment to continuous learning and professional development.