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.

Summary:

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, sampling requirements, reviews equipment challenges and that hourly in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record 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:

• Perform production line clearance inspections after product and lot changes.
• Evaluate equipment high-risk areas to drive line clearance excellence.
• Verifies first & last piece inspections to ensure finished goods code, format, and expiration date are correct.
• Ensure equipment is packaged within validated parameters.
• Ensures equipment calibration dates are current and that all process equipment are within required specifications.
• Performs in-line review of batch record (MPI) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately.
• Confirms that hourly inspections are on track to be met according to the applicable sample size.
• Review product sampling pages to ensure samples have been taken, labelled, and documented appropriately.
• Performs product quarantine of impacted materials including accumulation totals, confirming segregation and negative issuing of effected product and/or materials.
• Reviews Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks for completeness, accuracy, and legibility.
• Confirm package (unit) functionality (perforation, peel, push, seals, etc.).
• Ensures portable equipment has been 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.
• Confirms 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 PCI, cGMP, and GCP policies, procedures and rules.
• May perform duties of Label Technician.
• Perform other duties as assigned by Manager/Supervisor.
• Shift is 8:00am-4:30pm

Qualifications

Required

• High School Diploma or GED
• 1+ years experience in documentation review and/or applicable experience/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.
• High attention to detail. Must be able to address and identify operational discrepancies.

Preferred

• 1-5 years performing quality task within a cGMP environment.
• Ability to follow instructions and respond to management direction.
• Ability to work independently and/or part of a team.
• Ability to display excellent time management skills.

EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.