Reference #: JR106832Life 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: Quality AuditorDepartment/Group: QualityLocation: PhiladelphiaReports to: Quality Operation SupervisorFLSA Status: Non-ExemptSummary 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:Perform production room approvals after product and lot changes.Verifies first piece inspection to ensure finished goods code, format, on 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 (MPI) 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 requirementsReview sampling pages to ensure samples have been taken, labelled, and documented appropriatelyAudit 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 PDR's 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 neededWrite quality event notifications for issues encountered on the production floor. Ensure 5s Compliance.

　　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.

　　Must be dependable in work attendance.

　　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 vetera status, or any other protected status.

　　LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company's EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.