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Quality Assurance Specialist

2 months ago

Rockford, Illinois, United States QPS Employment Group Full time
Job Description

Job Title: Quality Assurance Specialist

Job Summary:

We are seeking a highly skilled Quality Assurance Specialist to join our team at QPS Employment Group. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and services, and for implementing quality control measures to prevent defects and errors.

Key Responsibilities:

  • Perform production room approvals after product and lot changes
  • Verify first piece inspection to ensure finished goods code, format, and expiration date are correct
  • Ensure equipment is packaged within validated parameters and equipment calibration dates on all process equipment are within required specifications
  • Review batch record to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately
  • Conduct periodic checks to confirm hourly inspections are being performed correctly and on track to meet requirements
  • Review sampling pages to ensure samples have been taken, labeled, and documented appropriately
  • Audit production room to ensure Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks have been completed accurately and timely
  • Confirm package (unit) functionality (perfs, peel, push, seals, etc.)
  • Check to ensure portable equipment has been cleaned and documented correctly on quality form
  • Audit production personnel to ensure the job is performed safely including wearing required personal protective equipment
  • Ensure recovery stations are segregated from product flow
  • Confirm bulk material and components for job are correct and kept covered
  • Review each equipment clean room logbooks for correct clean room, entries are complete, correct, and legible
  • Review temperature and humidity data to ensure within acceptable job parameters
  • Document audits using the Quality Auditor checklist listing the room, production job description, and date when the audit was conducted
  • Identify proactively gaps in batch records and to mitigate deviations and documentation errors
  • Participate on improvement teams (i.e., FMEA's, Kaizen, batch record etc.) as needed
  • Support Root Cause Analysis as needed
  • Ensure 5s (Sort, Set in order, Shine, Standardize, Sustain method) compliance
  • This position may require overtime and/or weekend work
  • Knowledge of and adherence to all company, cGMP (Current Good Manufacturing Practices), and GCP (Good Clinical Practices) policies, procedures, rules
  • Attendance to work is an essential function of this position

Requirements:

  • TABE Test for Adult Basic Education testing requirements met at approved grade level for position
  • Ability to perform basic computer tasks and has the ability to operate common computer programs
  • Ability to speak in a way that allows one to participate effectively in various conversations
  • Ability to read various types of standard items addressed to general readers
  • Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form
  • Ability to deal with problems that involve several concrete variables in standardized situations
  • Ability to demonstrate attention to detail
  • Ability to exhibit sound and accurate judgment
  • Ability to hold oneself in a professional manner
  • Ability to display excellent time management skills