Quality Assurance Senior Associate

Title: Regulatory/QA Sr. Associate
Type: Direct Hire
Location: Morris County, NJ
Hours: 9am-5pm (Hybrid schedule) .

Must have:

1. Strong experience with product supplier approvals
2. PCQI Certification – Preventive Controls Qualified Individual certification is expected. Will consider willing to do certification
3. Min 3–5 Years QA Experience in Food Industry – Direct experience in Quality Assurance within food, nutraceutical, or supplement sectors.
4. Knowledge of U.S. FDA Regulations – Familiarity with dietary ingredient regulations, HACCP/HARPC, and quality/compliance standards
5. Understanding of FSVA (Foreign Supplier Verification Program) and FSMA (Food Safety Modernization Act)
6. Strong Documentation Review Skills – Ability to assess technical documents such as SDSs, Specifications, Allergen/GMO statements, etc.
7. 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