Commercial Quality Inspector (WKND A)
 PCI Pharma Services | |
 United States, Illinois, Rockford | |
 Nov 23, 2024 | |
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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Job Title: Commercial Quality Inspector Department/Group: Quality Operations Location: Assembly Dr. Shift: WKND A (7am-7pm) Summary of Objective: This position is responsible for providing the direction, organization, alignment, monitoring and cGMP compliance to ensure the successful, cost effective, timely and safe processing of customer orders. The position audits production room documentation, checks equipment challenges and hourly in-process inspections have been performed, ensures samples have been taken, and reviews room for 5S Compliance. These associates are responsible for performing real time batch record and documentation review during batch processing in order to drive improvements into our Right First Time (RFT) metrics. They are also responsible for leading and realizing continuous quality and process improvements on the production floor by mentoring, coaching and training their operational counterparts. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Perform line clearance inspections after room cleans. Verifies 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 in real time 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 AQL 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 ATS's to mitigate deviations and documentation errors. Participate on improvement teams (i.e. FMEA's, Kaizen, batch record etc.) as needed May require use of Personal Protective Equipment (PPE) and Powered Air Purifying Respirator (PAPR). Support Root Cause Analysis as needed. Ensure 5s Compliance This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day. This position may have the following special vision requirements.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
The noise level in the work environment is typically, loud. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required:
Preferred:
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