QA Regulatory Compliance Label Control Specialist
JW NUTRITIONAL LLC · Allen, Texas, United States
Wellness and Fitness Services · 51-200 employees
About the role
The specialist is responsible for controlling and reconciling labels while ensuring regulatory compliance with FDA 21 CFR 111 standards. They also conduct facility audits, manage documentation, and enforce company policies and SOPs to maintain quality standards.
What they look for
Requirements
Candidates must have a high school diploma and a strong understanding of FDA Good Manufacturing Practices for dietary supplements. Proficiency in MS Office and Google Suite, along with excellent communication and analytical skills, is required.
Full description
Job DetailsJob Location: JW Nutritional LLC Fulfillment Center - Allen, TX 75013Job Shift: Day
QA RC Label Control Specialist
Duties:
Control and reconcile labels. This includes, but is not limited to, inspecting, receiving, issuing, and reconciling labels and label counts, as well as differentiating and separating different label revisions.
Provide customer service when needed, particularly in the form of providing inventory counts when requested.
Use Google Sheets and other company-specific methods of communication.
Regulatory compliance in accordance with FDA 21 CFR 111 guidance.
Identify nonconformances, perform investigations, and implement CAPAs, as necessary.
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, organization, etc.
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 any cleaning issues; direct cleaning team to ensure overall facility cleanliness.
Enforce all of the above through employee warnings and/or write-ups.
Halt production, if necessary.
Support Company policies, procedures, and work-rules and ensure that department employees comply with policies, standards, and work-rules.
Performs other duties as needed/requested by senior management.
Reports To: QA Regulatory Compliance SupervisorQualificationsRequired Skills:
Basic math skills
Excellent oral and written communication and interpersonal skills
Bilingual in English and Spanish, preferred but not required
Education/Certification:
Minimum high school diploma
Required Knowledge:
Proficient in all MS Office and Google Suite products
Required Experience
Forklift experience preferred, but not required
Strong organizational, analytical, and problem-solving skills
Strong understanding of current FDA Good Manufacturing Practices (GMPs) for Dietary supplements.
Working Conditions and Physical Requirements:
Quality Assurance covers all areas of the facility and manufacturing. The majority of this position is performed in the warehouse areas.
Prolonged periods sitting at a desk and working on a computer.
Must be able to lift up to 35 pounds at times.
Other physical requirements include, but are not limited to, stooping, bending, squatting, and reaching
