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 Associate 1 at our Safety Assessment Facility in Ashland, OH.
Basic Summary: Assist with implementing and monitoring quality control (QC) standards, methods and procedures. Present to and mentor technical personnel in proper and timely QC practices resulting in reduction of errors and deviations, encourage reduction of QA findings, and improve/enhance overall data quality.
ESSENTIAL DUTIES AND RESPONSIBLITIES:
- Assist in implementing quality control standards, methods and procedures
- Teach and mentor technical personnel concerning proper, timely QC practices.
- Monitor and track common deviations and problem documentation and investigate to determine root causes.
- Perform general QC practices and suggest solutions
- Complete follow up activities to reduce errors, deviations, and misunderstandings.
- Assist in recommending form and SOP modifications, and changes to standard protocol wording to avoid deviations.
- Assist in maintaining and revising QC documents, processes, manuals, and reports.
- Assist in updating QC guidance documents.
- Assist in providing individual and group training of laboratory personnel concerning effective and appropriate data documentation practices, common hand-recording mistakes, appropriate and clear error documentation/resolution, effective data QC reviews, and related QC practices.
- Perform QC reviews of study data and reports.
- Perform facility inspections.
- Perform all other duties assigned.
Education: H.S. diploma or General Equivalency degree (G.E.D) or equivalent required. Associate's (A.A./A.S.) degree in a scientific disciplined preferred.
Experience: Two to four years related experience in a GLP environment required. Previous and broad QC or QA experience preferred. Knowledge and/or background in preclinical technical functions also preferred.
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure: NoneJob Qualifications 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 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.