Quality Assurance Coordinator
hrEdge Consulting
- Florida, New York, United States
- Florida, New York, United States
Über
Status: Full‑time, non‑exempt Location: Oldsmar, FL (on‑site) Salary: $26.00‑$28.00/hour
Key Responsibilities
Quality System Management
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
Bachelor's 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
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, 401(k), PTO, and more.
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Sprachkenntnisse
- English
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