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For 75 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

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. Monitor and track common errors and assist with document modification to reduce error and deviations.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

* 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

* Assist in reviewing deviations for cause and providing effective communication/training programs to decrease the number of deviations per study.

* Perform QC reviews of study data and reports.

* Perform facility inspections.

* Perform other duties as assigned.

Job Qualifications

* Education: H.S. diploma or General Equivalency degree (G.E.D.) or equivalent preferred. Bachelor’s degree (B.S./B.A.) desired.

* Experience: 1-2 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: None.

* Other: Demonstrated leadership and word processing skills. Effective written, verbal and communication skills.

The pay range for this position is $19.00/hr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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 20,000 employees within 110 facilities in over 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.

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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex (including sexual orientation, gender identity, and expression), religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 [email protected]. 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 www.criver.com.

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