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Quality Assurance Specialist
2 months ago
We are seeking a detail-oriented Quality Auditor to join our team at IntePros. As a Quality Auditor, you will play a crucial role in ensuring the successful processing of customer orders while maintaining compliance with cGMP regulations.
Key Responsibilities:- Conduct production line clearance inspections after product and lot changes to ensure accuracy and compliance.
- Evaluate equipment high-risk areas to drive line clearance excellence and minimize errors.
- Verify first and last piece inspections to guarantee finished goods meet quality standards.
- Ensure equipment is packaged within validated parameters to prevent defects.
- Verify equipment calibration dates and specifications to maintain quality control.
- Perform in-line review of batch records to ensure equipment challenges and hourly inspections are conducted and addressed appropriately.
- Confirm hourly inspections are on track to meet sample size requirements.
- Review product sampling pages to ensure samples are taken, labelled, and documented correctly.
- Perform product quarantine of impacted materials, including accumulation totals and segregation of materials.
- Review Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks for completeness, accuracy, and legibility.
- Confirm package functionality and ensure portable equipment is cleaned and documented correctly.
- Review and confirm PPE attire aligns with batch record instructions.
- Ensure recovery stations are segregated from product flow.
- Confirm bulk material and components for production orders are correct, documented, and 'checked by' via second signature.
- Verify temperature and humidity data is within acceptable job parameters.
- Document audits using the Quality Auditor checklist, listing the room, production job description, and date when the audit was conducted.
- Proactively identify gaps in batch records to mitigate deviations and documentation errors.
- Support Root Cause Analysis as needed.
- Write quality event notifications for issues encountered within operations.
- Ensure 5s Compliance is followed during packaging.
- This position may require overtime and/or weekend work.
- Must have knowledge of and adherence to all clients, cGMP, and GCP policies, procedures, and rules.
- High School Diploma or GED and/or 1-3 months related experience and/or training.
- Basic Mathematical Skills
- Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.
Preferred qualifications include experience working within a cGMP environment, ability to follow instructions and respond to management direction, ability to work independently and/or part of a team, and ability to display excellent time management skills.
