Quality Assurance Coordinator
Job Summary
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.
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.
Complaints Investigations & CAPA
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 non- conformance.
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.
Supplier Quality & Compliance Support
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.
Labeling & Regulatory Support
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.
Training & Continuous Improvement
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.
Required Qualifications:
Bachelors degree preferred or equivalent combination of education and relevant experience.
25 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.
Required Skills & Experience:
Experience with the following:
Complaint handling
Investigations and root cause analysis
CAPA systems
Controlled documentation
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.
Preferred Qualifications:
Experience with pet food animal supplements or FDA-regulated products.
Working knowledge of the following:
FDA-regulated quality systems
21 CFR Part 507
NASC quality expectations
Basic labeling principles
Experience supporting audits or inspections.
Experience maintaining controlled quality documentation and records.
Lean/continuous improvement experience is a plus.
Work Environment:
Combination of office warehouse and operational environments.
Fast-paced regulated business environment requiring attention to detail professionalism and adaptability.
Periodic interaction with warehouse inventory product samples and operational activities may be required.
Location:
This position is 100% on site 5 days a week in Oldsmar Florida area.
Benefits:
We offer an extremely competitive benefits package including medical dental vision 401k PTO and more.