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Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
Position Title: Quality Auditor
Location: Philadelphia, PA
Department: Quality (Operations)
Shift: 1st shift weekends Friday-Sunday 8:00am-8:00pm
Reporting To: Quality Ops Supervisor
Responsible For (Staff): No
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, 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.
Essential Duties and Responsibilities:
Perform production line clearance inspections after product and lot changes.
Evaluate equipment high-risk areas to drive 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, confirming segregation and negative issuing of effected product and/or materials.
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 PCI, cGMP, and GCP policies, procedures and rules.
May perform duties of Label Technician.
May perform duties as Quality Coordinator.
Perform other duties as assigned by Manager/Supervisor.
Shift is Friday-Sunday 8:00am-8:00pm
Special Demands:
less than 1/4 of the day.
Ability to focus No Special Vision Requirements
Work Environment:
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time:
Qualifications:
Required
Preferred
Join us and be part of building the bridge between life changing therapies and patients.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.Full Time
$48k-61k (estimate)
07/24/2023
06/08/2024
The job skills required for Quality Auditor (1st shift weekends) include Futures, Time Management, Process Improvement, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Auditor (1st shift weekends). That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Auditor (1st shift weekends). Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Quality Auditor (1st shift weekends) positions, which can be used as a reference in future career path planning. As a Quality Auditor (1st shift weekends), it can be promoted into senior positions as an Internal Auditor III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Quality Auditor (1st shift weekends). You can explore the career advancement for a Quality Auditor (1st shift weekends) below and select your interested title to get hiring information.
If you are interested in becoming a Quality Auditor, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Auditor for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Auditor job description and responsibilities
They create testing parameters for products and services, develop quality control procedures, perform audits, and oversee quality control teams.
02/14/2022: Vincennes, IN
Some quality auditors are only responsible for checking a specific element of a product, such as consumer safety or standards compliance.
03/20/2022: Cedar Rapids, IA
Quality Auditors are usually part of a quality control team. Most quality auditors have a high school diploma or GED certificate.
03/12/2022: Springfield, MA
Develops reports and presents them to managers, along with recommendations against vulnerable areas.
03/15/2022: Clearwater, FL
A good Quality Auditor ought to have the ability to multi task and prioritize a multitude of competing duties.
03/22/2022: Longview, TX
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Auditor jobs
Create support and establish authority.
01/16/2022: Washington, DC
Be appreciative and constructive.
01/06/2022: Albany, NY
Manage the documentation appropriately.
03/25/2022: Richland, WA
Always go for evidence-based decision making.
01/18/2022: Waterloo, IA
Completion of post-secondary industry-related coursework preferred. Certification by the American Society for Quality (ASQ) will be advantageous.
03/08/2022: Montgomery, AL
Step 3: View the best colleges and universities for Quality Auditor.