QA Regulatory Compliance Label Control Specialist

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 Supervisor

Required 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