Job Purpose

The Quality Assurance /Labeling Associate in the Packaging area is responsible for gathering and testing in-process samples, performing clearance inspections and handling rejected material. 

Essential Job Functions

• Conduct and document, according to GDP, QA activities related to packaging activities, including clearance inspections of areas, materials, and equipment.
• Maintain clean and safe work and storage areas.
• Perform in-process sampling and testing on packaged products OR Label receipt, inspection, and counting of incoming labeling materials in a timely and efficient manner.
• Perform clearance inspections of areas, equipment and materials.
• Perform reconciliations and yield calculations. 
• Review assigned batch documents for accuracy and completeness.
• Complete logbooks, production records, and other official documentation.
• Assure reject material and retains are properly stored each day.
• Properly handle reject and retain samples.
• Assure that Quality and Operations personnel are complying with GMPs and Mikart procedures.
• Secure the placement of received, quarantined labeling materials into inspection inventory.
• Perform calibrations of counting equipment, as required.
• Count labeling materials and make appropriate entries on count sheets.
• Inspect labeling materials for conformance to approved specifications.
• Prepare released labeling materials for transfer to Released Labeling, including their removal from inspection inventory in the Company ERP system and recording appropriate information on transfer documents.
• Prepare rejected labeling materials for destruction and complete required documentation, as necessary.
• Investigate and appropriately resolve any inventory discrepancies.
• Maintain and order supplies required for effective functioning of the quarantine labeling area.
• Maintain all receipt/release documentation for each lot of labeling materials in accordance with Company retention policies.
• Assist in packaging component sampling and testing. 

  Key Characteristics

• Strong attention to detail and concern for standards are essential.
• Experience with computers and basic typing skills are required.
• Strong mathematical skills are essential. 
• Mastery of the English language is required, bilingual (English/Spanish) is a plus.
• The individual selected for this role must be independent and detail-oriented. 

Education and Qualifications

• High School diploma or qualification in a technical discipline 
• 1 year relatable experience is preferred. 
• Level III and IV associates will have demonstrated competence in both the manufacturing and packaging areas.
• Must be able to work 1st shift hours (7:00am-3:30pm Monday-Friday)

Physical Demands

• Ability to function in a rapidly changing environment and balance multiple priorities simultaneously. 
• Sitting or standing for long periods and repetitive hand motions.
• Some lifting required.
• The ability to gown and work successfully in a clean room environment.
• The ability to wear a respirator if required.