Quality Auditor

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Job Title: Quality Auditor

Department/Group: Quality

Location: Philadelphia

Reports to: Quality Operations Supervisor

FLSA Status: Non-Exempt

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 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 production room approvals after product and lot changes.

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 (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 requirements.

Review sampling pages to ensure samples have been taken, labelled, 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 PDRs 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 needed.

Write 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.

May perform duties of Quality Coordinator

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 of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

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. Must be physically capable of performing the above duties with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or listen. The employee is frequently required to stand and walk. The employee is occasionally required to sit. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and periodic eye exams.

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 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 noise level in the work environment is usually moderate.

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.

Education Or Equivalent

High School Diploma required.

2 - 4 years relevant experience in production, equipment and or process Packaging, Pharmaceutical, Bio-Pharmaceutical, and/or Medical Device background is preferred.

Language Skills

Must possess good analytical skills and excellent verbal and written communication skills.

Must demonstrate effective listening, coaching and interpersonal communications skills.

Knowledge/Skills Requirements

Must be dependable and show initiative to improve safety, quality, throughput and cost performance.

Must be willing to work overtime and flexible regarding working on all 3 shifts.

Able to balance multiple issues simultaneously in a fast-paced environment.

Needs good problem-solving skills, should be detail oriented and well organized.

Computer Skills

Must be computer literate with experience using MS Office, Lotus Notes, spreadsheets, and ERP systems.

Strong troubleshooting and computer/software skills

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.