- 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
- 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
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Associate GLP Quality Assurance Auditor - Exton, United States - Pharmaron
Description
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:
What We're Looking For:
You have experience with quality assurance in a GLP environment.
Qualifications and Experience:
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.
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