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Quality Assurance Specialist
1 month ago
Quality Inspector
Job Summary:
We are seeking a Quality Inspector to join our team at QPS Employment Group. As a Quality Inspector, you will be responsible for ensuring the quality of our products and services. This is a 3rd shift position with the opportunity for hire.
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. If not, this individual will contact the appropriate personnel to recalibrate and/or remediate the issue.
- Review batch record to ensure equipment challenges and hourly inspections have been conducted and any nonconformances 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 Setup 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.