QA Regulatory Compliance Label Control Specialist

JW NUTRITIONAL LLC•McKinney, TX

1d•Onsite

About The Position

The QA Regulatory Compliance 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, as well as managing different label revisions. The specialist will also provide customer service by supplying inventory counts, utilizing Google Sheets and other company communication methods, identifying non-conformances, conducting investigations, and implementing CAPAs. Additionally, the role includes maintaining and updating the Quality System, creating/revising QA/QC documents, assisting with audits, and inspecting the facility and employees for compliance with SOPs and cleanliness standards. This position requires enforcing policies through employee warnings and potentially halting production if necessary, while supporting overall 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, particularly in supplying inventory counts when requested.
Utilize Google Sheets and other company-specific communication methods.
Ensure regulatory compliance in accordance with FDA 21 CFR 111 guidance.
Identify non-conformances, perform investigations, and implement CAPAs.
File documentation appropriately.
Maintain and update the current Quality System.
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.