Job 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
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