Senior Quality Assurance Manager

American River Nutrition; Hadley (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

American River Nutrition offers an opportunity for a Senior Quality Assurance Manager to oversee quality and food safety operations at their Massachusetts site. This position involves managing compliance with FDA regulations, directing quality management systems, and leading laboratory operations. The ideal candidate has extensive experience in quality assurance, strong leadership skills, and a thorough understanding of food safety standards.

Qualifications

• 10+ years of progressive quality assurance experience in food or dietary supplements.
• PCQI certified with experience in product release and QA in manufacturing.
• Experience managing lab operations and supplier quality management.

Responsibilities

• Lead site Food Safety Plan and ensure compliance with FDA regulations.
• Oversee quality-related activities and manage analytical testing.
• Collaborate with cross-functional teams to ensure food safety standards.

Skills

Leadership

Communication

Analytical Skills

Problem-solving

Education

Bachelor’s degree in food science, Chemistry, Biology or related technical field

Advanced degree preferred

Tools

Microsoft Office

Project management tools

Job description

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The Senior Quality Assurance Manager is responsible to lead all site-level quality and food safety operations at the Massachusetts manufacturing site, which produces annatto-derived ingredients through distillation.This role will serve as the site authority on quality systems, regulatory compliance, and product release. The Senior QA Manager will oversee the implementation of the Food Safety Plan, ensuring compliance with all applicable FDA regulations (21 CFR 111 and 117) and manage the site Quality management System (QMS).This position includes direct oversight of the on-site analytical laboratory and quality responsibilities for warehouse and production activities. The Senior Quality Manager will also oversee quality-related activities with co-manufacturer and be responsible for Foreign Supplier Verification Program (FSVP) compliance.

Responsibilities

Quality Systems & Compliance

• Be the site Preventive Controls Qualified Individual and manage Food Safety Plan in accordance with regulatory requirements
• Lead and manage site Food safety and Quality Management System (FSQMS). Including SOPs, change control, training and document control
• Oversee training programs for GMPs, HACCP /Food Safety, and Food Defense/Food Fraud
• Manage validation and verification activities of the site, including but not limited to: sanitation validation and verification, internal inspections, environmental monitoring.
• Manage contractors associated with food safety such as but not limited toPest Control, Sanitation, uniforms.
• Review and approve production batch records, ensuring compliance/conformance with specifications and regulatory requirements
• Handle production nonconformities in accordance with site SOPs, and where applicable handle deviations, corrective and preventive actions.
• Supervise day-to-day operations of the on-site analytical lab, leading routine testing, investigations into incidents, quality issues and complaints, as well as lead required stability studies; coordinate and review analytical testing performed by third-party laboratories
• Manage and develop 1-2 laboratory staff, including training, scheduling, and performance management
• Oversee QA processes related to on-site warehouse, including receiving, sampling, repacking, and storage
• Manage FSVP compliance, including verification activities and documentation for imported materials
• Oversee and or conduct audits of suppliers and co-manufacturing partners
• Serve as point of contact for FDA inspections, state authorities, customer audits and internal audits
• Drive site inspection readiness through walkthroughs, records review, and training
• Collaborate with cross-functional teams in Production, R&D, and Supply Chain to ensure quality and food safety standards are aligned and appropriately incorporated across the organization
• Monitor and analyze quality metrics, driving root cause analysis and corrective actions as necessary to drive continuous improvement initiatives and foster a proactive quality culture across the site
• Track and report quality metrics; conduct management reviews

Qualifications

• Bachelor’s degree in food science, Chemistry, Biology or related technical field (advanced degree preferred)
• Minimum 10 years of progressive quality assurance experience in food, dietary supplements or ingredient manufacturing
• Deep working knowledge of 21 CFR 117 and familiarity with 21 CFR 111
• PCQI certified with demonstrated experience in overseeing product release, production records review, and QA in a manufacturing environment
• Experience managing or supervising lab operations, including in-house testing
• Knowledge of supplier quality management and FSVP requirements
• Excellent communication, documentation, and leadership skills
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Access); project management tools a plus.
• Excellent analytical, communication, problem-solving, and decision-making skills

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Wellness and Fitness Services

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