Quality Assurance/Labeling Associate

Mikart, Inc.; Atlanta, Northern (GA, KY); Hybrid; USD 42,000 - 64,000; Full time

Job summary

Mikart is seeking a dedicated Quality Assurance / Labeling Associate for the Packaging area. The role focuses on testing in-process samples, conducting clearance inspections, and handling rejected materials to ensure product quality.

Responsibilities include documenting QA activities per GDP, maintaining clean areas, calibrating equipment, and ensuring accurate batch documentation while complying with GMPs and Mikart procedures. First shift: 7:00am-3:30pm, Monday-Friday.

Qualifications

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

Responsibilities

• Conduct and document QA activities related to packaging using GDP, including clearance inspections.
• Maintain clean and safe work and storage areas.
• Perform in-process sampling and testing on packaged products or inspect and count labeling materials.
• Perform clearance inspections of areas, equipment and materials.
• Perform reconciliations and yield calculations.
• Review batch documents for accuracy and completeness.
• Complete logbooks, production records, and documentation.
• Ensure proper storage of reject material and retains daily.
• Handle reject and retain samples appropriately.
• Ensure compliance with GMPs and Mikart procedures by QA and Operations staff.
• Secure placement of received labeling materials into inspection inventory.
• Calibrate counting equipment as required.
• Count labeling materials and record counts on sheets.
• Inspect labeling materials for conformance to specs.
• Prepare released labeling for transfer to Released Labeling, documenting transfers.
• Prepare rejected labeling for destruction and documentation.
• Investigate inventory discrepancies.
• Maintain supplies for quarantine labeling area.
• Maintain receipt/release documentation for each labeling lot.
• Assist in packaging component sampling and testing.

Skills

Attention to detail

Typing skills

Mathematical skills

English proficiency

Independent

Bilingual

Education

High School diploma

Tools

ERP system

Job description

Description

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.

Requirements

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.