Commercial Quality Inspector Job at PCI Pharma Services
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JOB DESCRIPTION:
Position Title: Commercial Quality Inspector
Location: Rockford, Illinois – Assembly Drive
Department: Quality
Shift: 1st Shift
Reporting To: Quality Operations Supervisor
Responsible For (Staff): no
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, 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 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:
- 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.
QUALIFICATIONS:
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 accurate judgment.
- Ability to hold oneself in a professional manner.
- Ability to display excellent time management skills.
Equal Opportunity
Employer/Vet/Disabled
Join us and be part of building the bridge between life changing therapies and patients.
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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.
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.
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