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PCI Services
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 f
Job Source: PCI ServicesPackaging 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 IncCatalent Pharma Solutions
Philadelphia, PA, United States
**Quality Auditor** **Position Summary:** Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is co
Job Source: Catalent Pharma SolutionsPenn Foster
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 of Objective: This position
Job Source: Penn FosterParkside Informationstechnologie GmbH
Philadelphia, PA, United States
Für Software, die sich auf Dauer bewährt Um zusätzliche Kosten zu vermeiden, den ROI zu erhöhen und sicherzustellen, dass ein bestimmtes Softwareprodukt die Erwartungen vollständig erfüllt, ist es von entscheidender Bedeutung, einen klar definierten QA-Prozess zu haben und diesen in einem frühen Entwicklungsstadium zu implementieren. Bei Parkside
Job Source: Parkside Informationstechnologie GmbHGift of Life Donor Program
Philadelphia, PA, United States
Job Description Job Description Gift of Life Donor Program, is a non-profit agency servicing eastern Pennsylvania, southern New Jersey and Delaware. We are responsible for recovering organs and tissue used in life-saving and life-enhancing transplants. Join the nation’s leading organ donor program which coordinates more life-saving transplants t
Job Source: Gift of Life Donor ProgramVeriiPro
Philadelphia, PA, United States
We are seeking a highly motivated and detail-oriented Junior QA Analyst to join our quality assurance team. The successful candidate will be responsible for ensuring the quality and reliability of our software products through rigorous testing and validation processes. This role offers an opportunity to work in a dynamic environment and contribute
Job Source: VeriiProSageSure Insurance Managers
Philadelphia, PA, United States
Overview: If you're looking for the stability of a profitable, growing company with the entrepreneurial spirit of a startup, we're hiring. SageSure, a leader in catastrophe-exposed property insurance, is seeking a Director, Quality Assurance. In this pivotal role, you will ensure the quality of work we deliver to the market, communicate the appropr
Job Source: SageSure Insurance ManagersPhiladelphia, 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 global business. People are at the heart of our family-owned business and our values guide the way to our success. Team spirit and mutual support are very important to us. Our culture is characterised by strong international co-operation, can-do attitude, focus on quality and a growth mindset.
Our strength is to be where it matters - think globally, act locally!
YOUR TASKS
Inspect testing facilities to ensure framework is in place for studies to be conducted in compliance with GLP requirements.
Audit studies for compliance with GxP and with registration requirements:
Review draft protocol for compliance with GxP and the relevant test guideline
Inspect raw study data and statistical data
Inspect the in-life phase of a study as it’s being conducted
Review draft study report and check for accuracy of included raw data, completeness according to GxP principles and comparison with the relevant test guideline
Prepare inspection reports for each audit
Check if all findings specified in the inspection report have been addressed appropriate
The Quality Assurance Auditor is expected to:
Work independently
Audit complex studies
Serve as a point of contact for clients in order to provide solutions to problems with studies
Coach and review the work of less experienced Quality Assurance staff
Communicate and work in close co-operation with our clients and regulatory bodies
Work with other Quality Assurance staff to ensure reporting accuracy
Advise staff on GLP policies
Develop and maintain strong communication and working relationships with internal and external teams
Maintain all documentation and records that support the Quality Assurance function
Take a flexible approach to tasks and be prepared to undertake new and varied challenges
YOUR PROFILE
Essential Requirements
Detailed knowledge and understanding of one or more of the following guidelines:
GLP
GCP (VICH Topic GL9)
GMP
GDP
Minimum of a Bachelor’s degree (or equivalent experience) in a relevant scientific or veterinary discipline
Minimum of 2 years of relevant professional experience
Able to travel within the US approximately 25% of the time and/or commute to an office location in Ambler, PA once or twice a month.
Additional Preferences
Excellent language skills in English (spoken and written); additional language skills would be an asset
Excellent communication skills, both verbal and written
Excellent attention to detail, organizational skills, and ability to prioritize work
Ability to communicate mindfully and effectively with our clients and to identify additional client needs
Ability to work across multicultural teams in a global environment
Ability to provide stellar customer experience to clients in projects
WHAT WE OFFER
knoell offers competitive compensation and benefits package, including medical, dental, vision, life, disability, 401(k) with company match, and tuition reimbursement.
We are an Equal Opportunity Employer and do not discriminate on the basis of race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
knoell is a drug-free workplace. As a condition of employment, new hires may be required to pass a pre-employment drug test.
knoell complies with federal and state disability laws and makes reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, please contact our Recruiting department at [email protected] .
The above information on this description has been designed to indicate the general nature and level of work performed. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, qualifications and working conditions required of employees assigned to this job. While this is intended to be an accurate reflection of the job, management reserves the right to revise the job at any time .
We look forward to receiving your application!
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Email Alert for Quality Assurance Auditor jobs in Philadelphia, PA, United States
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