Quality Assurance/Labeling Associate

MikartAtlanta, GA
Onsite

About The Position

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. The individual selected for this role must be independent and detail-oriented. This role requires the ability to function in a rapidly changing environment and balance multiple priorities simultaneously. It involves sitting or standing for long periods and repetitive hand motions, with some lifting required. The ability to gown and work successfully in a clean room environment, and wear a respirator if required, is also necessary.

Requirements

  • Experience with computers and basic typing skills are required.
  • Strong mathematical skills are essential.
  • Mastery of the English language is required.
  • Must be able to work 1st shift hours (7:00am-3:30pm Monday-Friday)
  • Ability to gown and work successfully in a clean room environment.
  • Ability to wear a respirator if required.

Nice To Haves

  • Bilingual (English/Spanish) is a plus.
  • 1 year relatable experience is preferred.
  • Level III and IV associates will have demonstrated competence in both the manufacturing and packaging areas.

Responsibilities

  • 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.
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