Associate GLP Quality Assurance Auditor
2 weeks ago
Minimum of Bachelor's Degree in Life Sciences is required.
We are searching for a Quality Auditor with GLP experience to join our team. Is that you? If you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for.
This is an onsite position at our Exton, PA location.
What you will do:
The Associate GLP QA Auditor coordinates auditing activities to ensure compliance with SOPs and GLP requirements. Performs a wide variety of activities pertaining to assuring compliance with applicable regulatory requirements by conducting audits and inspections, supporting training programs, data and documentation reviews.
In addition:
- Audit each GLP study at intervals adequate to assure the integrity of the study and maintain documentation of each audit.
- Immediately notify the study director and management of any problems found during the audit which are likely to affect study integrity.
- Submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.
- Ensure that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.
- Review the final GLP study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the GLP study.
- Prepare and sign a statement to be included with the final GLP study report which shall specify the dates inspections were made and findings reported to management and to the study director.
- Maintain the Master Schedule.
- Prepare internal audit reports and communicate findings to internal stakeholders.
- Provide suitable recommendations for internal audit observations.
- Track audit responses and drive closure of CAPAs resulting from internal audits.
- Identify the potential compliance issues and champion continual process improvement.
- Provide support during Regulatory inspections and client audits
What We're Looking For:
You have experience with quality assurance in a GLP environment.
Qualifications and Experience:
- Bachelor's degree in the life sciences (e.g. biology, chemistry or a related field) Required
- 1-2 years of experience working in the pharmaceutical, biotechnology, or CRO industry.
- Experience working in a GLP environment.
- Knowledge of GLP regulations including 21 CFR Parts 11 and 58
Why Pharmaron?
Pharmaron is a premier contract research organization that offers a broad spectrum of R&D and manufacturing service capabilities throughout the entire drug discovery, preclinical, clinical development and commercialization process. With a workforce of over 20,000 professionals and operations spanning the U.S., U.K and China.
Our Culture: You'll thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners and collaborators.
Your benefit package: As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Plus, you'll have access to an Employee Assistance Program to support you in work and life.
Actual compensation may vary depending on job-related factors including knowledge, skills, and experience.
EEO/AA Statement:
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#LI-RA1
-
QA Specialist-GLP/BIO
40 seconds ago
Exton, United States Frontage Laboratories Full timeJob DescriptionJob Description Quality Assurance Specialist Bio-Analytical GLPLocation: Exton PAReports to: Director BIO GLP Quality assuranceFull-timePosition/Job Summary:Are you ready for a role that will combine your thirst for scientific knowledge and eye for quality. Then you are the perfect fit for our team of quality associates whose audits contribute...
-
Quality Assurance Associate
3 weeks ago
Exton, United States Pharmaron Full timeJob DescriptionJob DescriptionPosition Description: The Quality Assurance Associate will be responsible for upholding to quality standards at Pharmaron (Exton) Lab Services, by contributing to all Quality Systems within GMP Operations and reviewing quality data.Primary Responsibilities:Perform client data review and data pack assembly.Serve as primary...
-
Quality Assurance Analyst
2 weeks ago
Exton, United States INTERNET PIPELINE Full timeQuality Assurance Analyst - QUALI017377 DESCRIPTION/RESPONSIBILITIES: We are currently looking to add a QA Analyst to our team in. Summary: We are looking for an enthusiastic QA analyst to work on our Quality Assurance team. The candidate should have an affinity for all things digital, a talent for critical thinking, and a genuine passion for ensuring user...
-
Quality Assurance Analyst
1 month ago
Exton, United States iPipeline Inc Full timeWe are currently looking to add a **QA Analyst **to our team in. **Summary**: The QA Analyst works within our Quality Assurance team at the direction of a QA Manager to deliver high quality, effective and reliable solutions. **Responsibilities**: - Work with fellow members of the project team to understand the scope of project and release deliverables. -...
-
Associate Scientist-Biologics
1 day ago
Exton, United States Frontage Lab Full timeAssociate Scientist-Biologics Exton, PA (Corporate) Responsibilities: * Coordinate study activities with Responsible Scientist to ensure efficiency and quality * Aid in the preparation of study summaries and/or reports * Maintain the proper level of regulatory compliance for each study, helping to address QA audit findings * Ensure that GLP regulations...
-
Associate Scientist, Bioanalytical Services
21 hours ago
Exton, United States Frontage Lab Full timeAssociate Scientist, Bioanalytical Services Exton, PA (Corporate) Responsibilities * Associate Scientist / Bioanalytical Services Essential Functions Provide support for running sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment * Coordinate study activities with Responsible Scientist to ensure efficiency and quality *...
-
Associate Scientist, Bioanalytical Services
4 hours ago
Exton, United States Frontage Laboratories Full timeJob DescriptionJob DescriptionAssociate Scientist, Bioanalytical ServicesExton, PA (Corporate)ResponsibilitiesAssociate Scientist / Bioanalytical Services Essential Functions Provide support for running sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessmentCoordinate study activities with Responsible Scientist to ensure...
-
Quality Assurance Engineer
4 weeks ago
Exton, United States Genzeon Full timeRole: Quality Assurance EngineerEmployment Term: Fulltime with BenefitsLocation : Remote/With in USAQuality Assurance: Description: Seeking a meticulous and detail-oriented Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and reliability of our software products through rigorous...
-
Quality Assurance Engineer
4 weeks ago
Exton, United States Genzeon Full timeRole: Quality Assurance EngineerEmployment Term: Fulltime with BenefitsLocation : Remote/With in USAQuality Assurance: Description: Seeking a meticulous and detail-oriented Quality Assurance Engineer to join our team. As a Quality Assurance Engineer, you will be responsible for ensuring the quality and reliability of our software products through rigorous...
-
Associate Scientist-Biologics
12 hours ago
Exton, United States Frontage Laboratories Full timeJob DescriptionJob DescriptionAssociate Scientist-BiologicsExton, PA (Corporate)Responsibilities:Coordinate study activities with Responsible Scientist to ensure efficiency and qualityAid in the preparation of study summaries and/or reportsMaintain the proper level of regulatory compliance for each study, helping to address QA audit findingsEnsure that GLP...
-
Associate Scientist/scientist
1 day ago
Exton, United States Frontage Lab Full timeAssociate Scientist/Scientist - Biologics Service FTE team Full Time Exton PA or Client's site at Spring House PA Frontage Laboratories Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable life science companies to...
-
Director - Biomarker Services
1 day ago
Exton, United States Frontage Lab Full timeBiomarker Service Director Full-time Location: on site (Exton, PA) Summary: The Biomarker Service Director plays a key role in scientific initiatives, helping the operations team to establish various methods and ensure the successful delivery of projects. Additionally, the Director fosters the growth and development of the scientific staff through...
-
Exton, United States Frontage Lab Full timeAssociate Scientist, Pharmaceutical Analysis-Small Molecule Exton, PA (Research) Responsibilities * Performs routine sample analysis and a variety of tasks to support product development, ensuring agreed timelines * Assists method development Performs method validation under supervision * Reports and resolves any unexpected issues under supervision *...
-
Director - Biomarker Services
1 day ago
Exton, United States Frontage Laboratories Full timeBiomarker Service DirectorFull-timeLocation: on site (Exton, PA)Summary:The Biomarker Service Director plays a key role in scientific initiatives, helping the operations team to establish various methods and ensure the successful delivery of projects. Additionally, the Director fosters the growth and development of the scientific staff through coaching,...
-
Scientist/Associate Scientist- Biomarker
1 day ago
Exton, United States Frontage Lab Full timeFrontage Laboratories: Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism, pharmokinetics/ pharmacodynamics...
-
Associate Scientist/scientist
10 hours ago
Exton, United States Frontage Laboratories Full timeJob DescriptionJob DescriptionAssociate Scientist/Scientist – Biologics Service FTE teamFull TimeExton PA or Client’s site at Spring House PAFrontage LaboratoriesFrontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throughout the drug discovery and development process to enable...
-
Director - Biomarker Services
2 hours ago
Exton, United States Frontage Laboratories Full timeJob DescriptionJob DescriptionBiomarker Service DirectorFull-timeLocation: on site (Exton, PA)Summary:The Biomarker Service Director plays a key role in scientific initiatives, helping the operations team to establish various methods and ensure the successful delivery of projects. Additionally, the Director fosters the growth and development of the...
-
Scientist/Associate Scientist- Biomarker
1 day ago
Exton, Pennsylvania, United States Frontage Laboratories Full timeJob DescriptionJob DescriptionFrontage Laboratories:Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage's core competencies include drug metabolism,...
-
Scientist/Associate Scientist- Biomarker
2 days ago
Exton, United States Frontage Laboratories Full timeJob DescriptionJob DescriptionFrontage Laboratories:Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Frontage’s core competencies include drug metabolism,...
-
Director QA, Pharmaceutical Manufacturing
7 hours ago
Exton, United States Frontage Laboratories Full timeJob Description Job Description Director of Quality Assurance, Pharmaceutical Manufacturing Title: Director of Quality Assurance, Pharmaceutical Manufacturing Location: Exton, PA Reports to : James Huang, Global Vice President, Quality Assurance, and IT Compliance Position type : Full-time. Frontage Laboratories Inc. is an award winning, publicly listed...