What are the responsibilities and job description for the Quality Assurance Manager position at Everwell Health?
The 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. The 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 quality responsibilities for warehouse and production activities. The Quality Manager will also oversee quality-related activities with co-manufacturers and be responsible for supply chain preventive control, including approval and Foreign Supplier Verification Program (FSVP) compliance.
Key Responsibilities:
Quality Systems & Compliance
- Promote a strong culture of quality and food safety through the site
- Be the site Preventive Controls Qualified Individual and manage Food Safety Plan in accordance with regulatory requirements
- Lead and manage site Preventive controls-based 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 recall program and ensure traceability is maintained throughout the supply chain.
- Manage contractors associated with food safety such as but not limited to Pest 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.
- Lead investigations into incidents, quality issues and complaints.
- Oversee QA processes related to on-site warehouse, including receiving, sampling, repacking, and storage
- Manage supplier approval and 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, Laboratory, 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
- Track and report quality metrics; conduct management reviews
Leadership & People Development
· Lead, mentor, and develop a QA team and as needed, contractors (1-3 FTE)
· Perform staffing, training, performance management
· Foster a culture of quality, food safety, and compliance
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
- 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
Location and Travel:
· This role is based in Hadley, MA. May include travel up to 20%.
Pay: $125,000.00 - $145,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person
Salary : $125,000 - $145,000