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:
· 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.
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.
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