Quality Auditor

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 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 partners with production to review 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.

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.
• Review 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.
• Guide 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.
• 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.

Supervises site QA operations, including management of incoming and in-process QA inspectors/auditors, batch record preparation, batch record review, document change control, training, CAPA and quality metrics.

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.

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

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 with 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, through put and cost performance.

Must be willing to work overtime and flexible in regard to 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

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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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.