Quality Auditor

1 week ago

Philadelphia, United States IntePros Full time

IntePros is currently looking for a Quality Auditor to join one of our premier clients in Philadelphia, PA. The Quality Auditor 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, sampling requirements, reviews equipment challenges and that hourly in-process inspections have been performed within compliance. The Quality Auditor performs real-time batch record 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.

Quality Auditor Responsibilities

  • Perform production line clearance inspections after product and lot changes.
  • Evaluate equipment high-risk areas in driving line clearance excellence.
  • Verifies first & last piece inspections to ensure finished goods code, format, and expiration date are correct.
  • Ensure equipment is packaged within validated parameters.
  • Ensures equipment calibration dates are current and that all process equipment are within required specifications.
  • Performs in-line review of batch record (MPI) to ensure equipment challenges and hourly inspections have been conducted and any non-conformances are addressed appropriately.
  • Confirms that hourly inspections are on track to be met according to the applicable sample size.
  • Review product sampling pages to ensure samples have been taken, labelled, and documented appropriately.
  • Performs product quarantine of impacted materials including accumulation totals, reviewing segregation of materials and negative issuing of impacted product and/or components.
  • Reviews Cleaning and Use logbooks, Mechanical Set-up logbooks, and Preventive Maintenance logbooks for completeness, accuracy, and legibility.
  • Confirm package (unit) functionality (perforation, peel, push, seals, etc.)
  • Ensures portable equipment has been cleaned and documented correctly.
  • Review and confirm PPE attire aligns with batch record instructions.
  • Ensure recovery stations are segregated from product flow.
  • Confirm bulk material and components for production orders are correct, documented and ‘checked by’ via second signature.
  • Confirms temperature and humidity data is within acceptable job parameters.
  • Document audits using the Quality Auditor checklist listing the room, production job description, and date when the audit was conducted.
  • Proactively identify gaps in batch records to mitigate deviations and documentation errors.
  • Support Root Cause Analysis as needed.
  • Write quality event notifications for issues encountered within operations.
  • Ensure 5s Compliance is followed during packaging.
  • This position may require overtime and/ or weekend work
  • Must have knowledge of and adherence to all clients, cGMP, and GCP policies, procedures and rules.
  • May perform duties of Label Technician.
  • Perform other duties as assigned by Manager/Supervisor.

Quality Auditor 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: From 1/2 to 3/4 of the day.
  • Install, place, adjust, apply, measure, use, or signal: None.
  • Ascend/Descend or Work Atop: Up to 1/4 of the day.
  • Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
  • 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 10 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

Quality Auditor Work Environment

  • 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 1/4 to 1/2 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 1/4 to 1/2 of the day.
  • Extreme cold (non-weather) For up to 1/4 of the day.

Required

Quality Auditor Qualifications:

  • High School Diploma or GED and/or 1-3 months related experience and/or training.
  • Basic Mathematical Skills
  • Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred

  • Experience working within a cGMP environment.
  • Ability to follow instructions and respond to management direction.
  • Ability to work independently and/or part of a team.
  • Ability to display excellent time management skills.

  • Quality Auditor

    3 weeks ago

    Philadelphia, United States QPS Employment Group Full time

    Position Title: Quality Auditor Wage: $22.00 per hour Shift: 2nd, 3rd QPS Employment Group is seeking a dedicated Quality Auditor to join a packaging company in a clean, temperature-controlled environment. The ideal candidate will have experience in a cGMP environment and adhere to Good Documentation Practices (GDP). This role involves working...

  • IntePros | Quality Auditor | philadelphia, pa

    6 days ago

    philadelphia, United States IntePros Full time

    IntePros is currently looking for a Quality Auditor to join one of our premier clients in Philadelphia, PA. The Quality Auditor 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...

  • IntePros | Quality Auditor | philadelphia, pa

    1 week ago

    philadelphia, United States IntePros Full time

    IntePros is currently looking for a Quality Auditor to join one of our premier clients in Philadelphia, PA. The Quality Auditor 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...

  • Night Auditor

    3 weeks ago

    Philadelphia, United States HYATT Hotels Full time

    Hyatt Hotels - 200 South Broad Street [Front Desk Agent / Reservations Agent] As a Night Auditor at Hyatt Hotels, you'll: Be responsible for the preparation and disposition of all Night Audit work; Be responsible for all Hotel Host functions during the overnight shift; Contribute to the hotel's commitment to high quality guest service and teamwork...Hiring...

  • DOCM Sr. Auditor

    1 month ago

    philadelphia, United States Proclinical Staffing Full time

    DOCM Senior Auditor - Contract - Philadelphia PAProclinical is seeking a Senior Auditor to support our clinical research mission. Primary Responsibilities:The ACC clinical research portfolio comprises hundreds of studies with many being conducted across the US and in other countries. The Sr. Auditor is responsible for scheduling, coordinating and conducting...

  • DOCM Sr. Auditor

    1 month ago

    Philadelphia, United States Proclinical Staffing Full time

    DOCM Senior Auditor - Contract - Philadelphia PAProclinical is seeking a Senior Auditor to support our clinical research mission. Primary Responsibilities:The ACC clinical research portfolio comprises hundreds of studies with many being conducted across the US and in other countries. The Sr. Auditor is responsible for scheduling, coordinating and conducting...

  • DOCM Sr. Auditor

    1 month ago

    philadelphia, United States Proclinical Staffing Full time

    DOCM Senior Auditor - Contract - Philadelphia PAProclinical is seeking a Senior Auditor to support our clinical research mission. Primary Responsibilities:The ACC clinical research portfolio comprises hundreds of studies with many being conducted across the US and in other countries. The Sr. Auditor is responsible for scheduling, coordinating and conducting...

  • Night Auditor

    6 months ago

    Philadelphia, United States Davidson Hospitality Full time

    Overview Are you a detail-oriented individual who thrives in a fast-paced environment? Join our team as a Night Auditor and play a crucial role in ensuring the smooth operation of our hotel during the night hours. We are seeking a dedicated and responsible individual who is passionate about providing exceptional guest experiences and is ready to take...

  • Night Auditor

    3 months ago

    Philadelphia, United States Concord Hospitality Full time

    Description The DoubleTree suites Philadelphia West located in Plymouth Meeting is seeking a Full time Night Auditor to join our Front Office Team! We are looking for people that have a passion to serve others! Working at the front desk means you are at the hub of the hotel with the most interaction with our guests. Your role is key to the overall experience...

  • Compliance Auditor

    4 weeks ago

    Philadelphia, United States Thomas Jefferson University & Jefferson Health Full time

    PRIMARY FUNCTION: Under general supervision, using a unique combination of clinical expertise and billing knowledge, the Compliance Auditor monitors and improves the quality of clinical and financial documentation related to the provision of patient services. The Compliance Auditor will compare clinical and financial records to ensure that the documentation...

  • Senior Internal Auditor

    4 weeks ago

    Philadelphia, United States Children's Hospital of Philadelphia Full time

    SHIFT: Day (United States of America) Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your...

  • Quality Engineer

    3 weeks ago

    Philadelphia, United States Vertiq Full time

    Company: VertiqJob Title: Quality EngineerReports To: The Quality Engineer will report to the Director of Manufacturing.Company Overview: Vertiq is a Philadelphia-based startup that makes advanced propulsion systems for commercial and defense aerial vehicles. Vertiq spun out of the University of Pennsylvania’s robotics lab with the goal of perfecting the...

  • Quality Engineer

    3 weeks ago

    philadelphia, United States Vertiq Full time

    Company: VertiqJob Title: Quality EngineerReports To: The Quality Engineer will report to the Director of Manufacturing.Company Overview: Vertiq is a Philadelphia-based startup that makes advanced propulsion systems for commercial and defense aerial vehicles. Vertiq spun out of the University of Pennsylvania’s robotics lab with the goal of perfecting the...

  • Quality Engineer

    3 weeks ago

    philadelphia, United States Vertiq Full time

    Company: VertiqJob Title: Quality EngineerReports To: The Quality Engineer will report to the Director of Manufacturing.Company Overview: Vertiq is a Philadelphia-based startup that makes advanced propulsion systems for commercial and defense aerial vehicles. Vertiq spun out of the University of Pennsylvania’s robotics lab with the goal of perfecting the...

  • IntePros | Manufacturing Associate | philadelphia, pa

    4 days ago

    philadelphia, United States IntePros Full time

    IntePros is currently looking for a Manufacturing Associate to join one of our premier clients in Philadelphia, PA. The Manufacturing Associate 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...

  • IntePros | Manufacturing Associate | philadelphia, pa

    2 days ago

    philadelphia, United States IntePros Full time

    IntePros is currently looking for a Manufacturing Associate to join one of our premier clients in Philadelphia, PA. The Manufacturing Associate 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...

  • Senior Regulatory Coordinator

    1 week ago

    Philadelphia, United States Temple Health – Temple University Health System Full time

    Cancer Therapy Evaluation Program (CTEP) annual registration which is required for all persons participating in any NCI-sponsored clinical trial. Sr NCI Regulatory Coordinator is responsible for the accurate compilation and s, modifications and continuing reviews for protocols funded by the National Institute of Cancer (NCI). The Sr NCI Regulatory...

  • Temple Health – Temple University Health System | Senior Regulatory Coordinator

    1 week ago

    philadelphia, United States Temple Health – Temple University Health System Full time

    Cancer Therapy Evaluation Program (CTEP) annual registration which is required for all persons participating in any NCI-sponsored clinical trial. Sr NCI Regulatory Coordinator is responsible for the accurate compilation and s, modifications and continuing reviews for protocols funded by the National Institute of Cancer (NCI). The Sr NCI Regulatory...

  • Corporate Controller

    1 month ago

    Philadelphia, United States Robert Half Full time

    Job DescriptionJob DescriptionRobert Half is in search of a Corporate Controller for our vibrant Philadelphia-based client. The responsibilities of this role include guiding and controlling the company's activities related to corporate accounting and finance, while maintaining adherence to GAAP and other mandatory standards. The ideal candidate will...

  • Temple Health – Temple University Health System | Senior Regulatory Coordinator

    6 days ago

    philadelphia, United States Temple Health – Temple University Health System Full time

    Cancer Therapy Evaluation Program (CTEP) annual registration which is required for all persons participating in any NCI-sponsored clinical trial. Sr NCI Regulatory Coordinator is responsible for the accurate compilation and s, modifications and continuing reviews for protocols funded by the National Institute of Cancer (NCI). The Sr NCI Regulatory...