System One Holdings, LLC

Compensation

Full Description

Title: Regulatory/QA Sr. Associate Type: Direct Hire Location: Morris County, NJ Hours: 9am-5pm (Hybrid schedule) . Must have: • Strong experience with product supplier approvals • PCQI Certification - Preventive Controls Qualified Individual certification is expected. Will consider willing to do certification • Min 3-5 Years QA Experience in Food Industry - Direct experience in Quality Assurance within food, nutraceutical, or supplement sectors. • Knowledge of U.S. FDA Regulations - Familiarity with dietary ingredient regulations, HACCP/HARPC, and quality/compliance standards • Understanding of FSVA (Foreign Supplier Verification Program) and FSMA (Food Safety Modernization Act) • Strong Documentation Review Skills - Ability to assess technical documents such as SDSs, Specifications, Allergen/GMO statements, etc. • Proficiency in Microsoft Office and CRM/QMS Tools - Skilled in Excel, Word, Outlook; experience with Salesforce and Compliance Quest is preferred Responsibilities • Review and assess supplier-provided documents (SIDIs), including Specifications, Safety Data Sheets (SDSs), Flow Charts, Allergen and GMO statements, BSE/TSE documentation, Nutritional data, Test Methods, and third-party certifications. • Bulk of the role is conducting product and supplier approvals in accordance with established SOPs and regulatory guidelines. • Manage change control processes by evaluating supplier changes, gathering updated documentation, and ensuring timely internal and external communication. • Respond to customer documentation inquiries related to products and facilities. • Confirm alignment between customer and supplier specifications for product approvals, customer orders, and requests. • Oversee product release processes, ensuring all items meet specification and testing requirements prior to distribution. • Maintain and upload current technical documentation and data into Compliance Quest. • Support the handling of sample requests, including proper storage, tracking, and dispatch along with required documentation. • Execute additional responsibilities as assigned by the Associate Director, Quality or Vice President, Quality. The Quality Assurance Senior Associate plays a key role in maintaining and enhancing product quality and regulatory compliance. Reporting to the Associate Director of Quality, this position partners cross-functionally with teams including Operations, Sales, Medical & Scientific Affairs, and Innovation. We are seeking a proactive, solution-oriented professional who brings a consultative approach and strong attention to detail to improve both partner and customer outcomes. QUALIFICATIONS Technical Knowledge • Understanding of food or ingredient specifications, including assays, contaminants, allergens, GMOs, and flow charts • Ability to interpret Certificates of Analysis (CoAs) and regulatory documents • Familiarity with FDA guidelines and industry standards for testing and compliance • Knowledge of supplier and product approval processes Analytical Thinking and Problem Solving • Ability to evaluate mismatched specifications and make informed decisions • Assess the severity and urgency of quality discrepancies • Handle unexpected issues, such as unlisted contaminants Communication and Collaboration • Strong communication skills across departments (Sales, QA, Regulatory, Customer Service) • Ability to explain technical issues to both technical and non-technical audiences • Skilled at coordinating and engaging with internal and external stakeholders Customer Focus and Risk Management • Align customer needs with internal quality standards • Balance customer satisfaction with regulatory and safety compliance • Manage risk in product testing, supplier validation, and release decisions Process Orientation and Compliance • Knowledge of internal release procedures and documentation standards • Ability to follow or develop fast-track processes while maintaining compliance Experience: • 3-5 years of Quality Assurance experience in the food industry. Certification: • PCQI certification required Ref: #558-Scientific