RFD_Commercial Quality Inspector

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.

Location: New Milford School Road

Shift: Monday - Thursday (5am-3pm)

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.

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:

• Skills testing requirements met at approved grade level for position.

• High School Diploma or GED and/or 1-3 months related experience and/or training.

• Basic Mathematical Skills

• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.   

• Minimum Professional Proficiency: 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.

• Intermediate Reasoning: 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.

Preferred:

• 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.  

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