Quality Assurance Auditor 1

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Job description

Quality Assurance Auditor 1

Req ID #: 131920

Location:

Ashland, OH, US, 44805

For 70 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we'll help you build a career that you can feel passionate about.

Job Summary

We are seeking a Quality Assurance Auditor 1 for our Safety Assessment site located in Ashland, Ohio.

The Quality Assurance (QA) Auditor performs audits of protocols, in-life critical phases; raw data and final reports of basic complexity and of routine study design conducted at the Testing Facility to assure accuracy and compliance with Good Laboratory Practice Regulations (GLP) and Standard Operating Procedures (SOP) and maintain written and signed records of auditing activities. The QA Auditor I applies discretion and independent judgment in providing recommended corrective actions to management and the study director. Additional responsibilities include: perform site Quality System audits (process/facility/equipment/validation) and review of corresponding regulatory documentation to ensure compliance; assist with qualification audits of subcontractors; may assist with sponsor/agency site audits; and participate in QA projects.

Responsiblities:

* Review protocols for compliance with all pertinent government and international GLP regulations for studies conducted at the Test Facility that are basic and routine in study design.
* Perform raw data audits for studies to ensure accuracy and compliance with the GLPs, study protocol and Standard Operating Procedures.
* Audit in-life critical phases of ongoing studies for compliance with the GLPs, study protocol and Standard Operating Procedures.
* Review final reports to ensure accuracy and compliance with GLP regulations and the study protocol/amendments; ensure that the final report accurately describes the raw data and study methods.
* Determine and assure that study deviations are appropriately reported and documented.
* Prepare and sign the Quality Assurance Statement to be included with audited final report.
* Prepare and review Quality Assurance files prior to Sponsor site visits; ensure that QA audit files are archived.
* Perform audits of site Quality Systems (process inspections; facility inspections; equipment and record review; computer validation activities; training records) including audits of corresponding regulatory documentation to ensure compliance.
* Assist in training of Quality Assurance personnel.
* Assist in providing and documenting company-wide GLP training sessions.
* May provide support during government/agency inspections, as requested.
* May assist in scheduling and tracking Quality Assurance audits inspections and procedures, as requested.
* Participate in qualification audits of subcontractors, as requested.
* Participate in Quality Assurance projects, as requested.
* Perform all other related duties as assigned.

Qualifications:

* Bachelor's degree (B.S. /B.A.) or equivalent, preferably in a life science or related discipline.
* Minimum of 1 to 2 years in a Quality Assurance role.
* An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

About Charles River

Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients' clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 17,000 employees within 90 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client's unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2019, revenue increased to $2.62 billion.

At Charles River, we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit .

Nearest Major Market: Cleveland

Nearest Secondary Market: Mansfield

Job Segment: Toxicology, Biotech, Quality Assurance, Pharmaceutical, Science, Technology, Research