QA Regulatory Compliance Label Control Specialist

JW NUTRITIONAL LLC•Allen, TX

8d•Onsite

About The Position

The QA RC Label Control Specialist will be responsible for controlling and reconciling labels, ensuring regulatory compliance with FDA 21 CFR 111 guidance. This role involves inspecting, receiving, issuing, and reconciling labels, differentiating label revisions, and providing inventory counts. The specialist will also identify nonconformances, conduct investigations, implement CAPAs, file documentation, maintain the Quality System, create/revise QA/QC documents, and assist with audits. Additionally, the role includes inspecting and auditing the facility and employees for cleanliness and adherence to SOPs, notifying management of significant issues, completing inspection documentation, directing cleaning efforts, and enforcing policies through warnings or write-ups. The specialist may halt production if necessary and must support company policies and procedures.

Requirements

Basic math skills
Excellent oral and written communication and interpersonal skills
Proficient in all MS Office and Google Suite products
Strong organizational, analytical, and problem-solving skills
Strong understanding of current FDA Good Manufacturing Practices (GMPs) for Dietary supplements.
Ability to lift up to 35 pounds at times.
Ability to perform stooping, bending, squatting, and reaching.

Nice To Haves

Bilingual in English and Spanish
Forklift experience

Responsibilities

Control and reconcile labels, including inspecting, receiving, issuing, and reconciling label counts.
Differentiate and separate different label revisions.
Provide customer service, including providing inventory counts when requested.
Ensure regulatory compliance in accordance with FDA 21 CFR 111 guidance.
Identify nonconformances, perform investigations, and implement CAPAs.
File documentation appropriately.
Maintain the current Quality System and update as needed.
Create and revise internal QA/QC documents.
Assist with audits.
Inspect and audit facility for cleanliness and organization.
Inspect and audit employees to ensure current in-house SOPs are being followed.
Notify Operations and Quality Assurance/Quality Control management of significant problems.
Complete documentation necessary to attest to satisfactory completion of inspections.
Check facility for cleaning issues and direct the cleaning team.
Enforce policies through employee warnings and/or write-ups.
Halt production, if necessary.
Support Company policies, procedures, and work-rules and ensure department employees comply.
Perform other duties as needed/requested by senior management.