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Packaging Coordinators Inc
Philadelphia, PA, United States
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: This position is responsible
Job Source: Packaging Coordinators IncXactus, LLC
Marple Township, PA, United States
Who We Are Xactus (pronounced ‘Zac-tus’) is the leading verification innovator for the mortgage industry. We have over 6,500 clients ranging from the largest bank and non-bank mortgage originators to credit unions and mortgage brokers. With 12 operation centers across the U.S., Xactus works closely with our clients to digitally integrate a 360° ap
Job Source: Xactus, LLCXactus
Marple Township, PA, United States
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law. Category Operations Description WHO WE ARE: Xactus (pronounced
Job Source: XactusKnoell
Philadelphia, PA, United States
knoell is one of the leading global service providers in offering regulatory registration, clinical development and product development support to clients. Our team of scientific and regulatory experts and extensive network of partners ensures that all the different regulatory requirements are right from the project outset to support our client’s g
Job Source: KnoellJefferson Health
Philadelphia, PA, United States
003306 PRIMARY FUNCTION : Coding Audit and Compliance Administrator has the responsibility for developing, implementing and maintaining a data quality compliance plan for inpatient and outpatient coding and reimbursement. The Coding Audit and Compliance Administrator will assist the Senior Director of Health Information Management and Director o
Job Source: Jefferson HealthKelly Services
Spring House
**Data Auditor (Quality Assurance)** Kelly Outsourcing & Consulting Group (Kelly OCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Data Auditor ( Quality Assurance) for a long-term engagement at one of our Global clients in Spring House, PA. This role is a full-time, fully benefitted position. As a
Job Source: Kelly ServicesMMS
Philadelphia
Job Description Job Description MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make
Job Source: MMSMMS Holdings Inc
Philadelphia, PA, United States
MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creati
Job Source: MMS Holdings IncPhiladelphia, PA, United States
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 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 (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 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 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 - 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
Qualifications: Required 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
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.
EQUAL OPPORTUNITY EMPLOYER/VETERANS/DISABLED 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.
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Quality Auditor jobs in Philadelphia, PA, United States
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Get ready to discover your next great opportunity.