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Job Title: Commercial Quality Inspector

Department/Group: Quality Operations

Location: Assembly Dr.

Shift: WKND A (7am-7pm)

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 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: 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.

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

• Stationary Position: Under a 1/4 of the day.

• Move, Traverse: 3/4 of the day and up.

• Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.

• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.

• Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day.

• Position self (to) or Move (about or to): 3/4 of the day and up.

• Communicate or exchange information: 3/4 of the day and up.

• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision ☒ Distance Vision ☒ Color Vision ☒ Peripheral Vision ☒ Depth Perception

• Ability to focus ☐ No Special Vision Requirements

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 following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day.

• Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day.

• Work near moving mechanical parts for 3/4 of the day and up.

• Fumes or airborne particles for up to 1/4 of the day.

The noise level in the work environment is typically, loud.

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 accurage judgment.

• Ability to hold oneself in a professional manner.

• Ability to display excellent time management skills.

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled