Quality Assurance Coordinator

Swedencare North AmericaOldsmar, FL
$26 - $28Onsite

About The Position

The QA Specialist is responsible for supporting and ongoing development of Swedencare North America’s Quality Management System (QMS) for distributed and labeled animal health and pet supplement products. This role supports compliance and operational quality activities through management of investigations, CAPA, document control, supplier quality coordination, complaint handling, audit readiness, and controlled quality system processes. The position plays a critical role in maintaining an inspection-ready quality system aligned with FDA regulatory expectations, NASC requirements, and internal quality standards. This is a hands-on, detail-oriented role requiring strong documentation practices, critical thinking, and the ability to independently manage routine quality system activities within a regulated environment. This role will help support the continued development and maturation of quality systems and processes as the organization grows.

Requirements

  • Bachelor’s degree preferred or equivalent combination of education and relevant experience.
  • 2–5 years of experience in Quality Assurance, Compliance, Regulatory Support, or Quality Systems roles.
  • Experience working in regulated industries preferred, including food, pet products, dietary supplements, pharmaceuticals, medical devices or consumer packaged goods.
  • Experience with complaint handling
  • Experience with investigations and root cause analysis
  • Experience with CAPA systems
  • Experience with controlled documentation
  • Experience with supplier quality support
  • Strong written communication skills with the ability to document clearly, objectively, and accurately.
  • Strong organizational and follow-through skills.
  • Ability to manage multiple priorities and work independently with minimal supervision.
  • Comfortable interacting with internal teams, suppliers, and external partners.

Nice To Haves

  • Experience with pet food, animal supplements, or FDA-regulated products.
  • Working knowledge of FDA-regulated quality systems
  • Working knowledge of 21 CFR Part 507
  • Working knowledge of NASC quality expectations
  • Working knowledge of basic labeling principles
  • Experience supporting audits or inspections.
  • Experience maintaining controlled quality documentation and records.
  • Lean / continuous improvement experience is a plus.

Responsibilities

  • Maintain controlled quality documents, records, procedures, forms, and related QMS documentation in accordance with document control procedures.
  • Support document revisions, approvals, implementation, and change management activities.
  • Ensure quality records are complete, accurate, and inspection ready.
  • Manage and document customer complaints and adverse events, including investigation, follow-up, and closure activities.
  • Conduct routine quality investigations related to complaints, deviations, labeling discrepancies, supplier issues, distribution concerns, and nonconformances.
  • Document root cause analysis and support implementation, tracking, and effectiveness verification of corrective and preventive actions (CAPAs).
  • Escalate quality or compliance risks to Quality Management as appropriate.
  • Support supplier quality communications, documentation requests, qualification activities, and ongoing supplier quality record maintenance.
  • Assist with supplier corrective action follow-up and quality issue resolution activities.
  • Support audit preparation activities, corrective action tracking, and internal quality initiatives.
  • Perform quality review of labels, packaging, and related documentation for completeness, formatting, consistency, and alignment with approved claims and internal standards.
  • Escalate regulatory determinations or compliance concerns to Quality Management as appropriate.
  • Support training coordination and maintenance of training records related to QMS procedures and quality processes.
  • Participate in continuous improvement initiatives to strengthen quality system effectiveness and operational compliance.
  • Perform additional duties as assigned by the Quality Manager to support business and compliance needs.
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