QC Associate I:
Charles River Laboratories

29061-en_US
Charles River Laboratories
Skokie Illinois
Biotech
Description

For nearly 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 e perform. In return, we’ll help you build a career that you can feel passionate about.

 

 

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 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.

 

QUALIFICATIONS:

  • Education:    H.S. diploma or General Equivalency degree (G.E.D.) or equivalent required.  Associate’s (A.A./A.S.) degree in a scientific discipline 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: None.
  • Other: Demonstrated leadership and word processing skills.  Effective written, verbal and communication skills. 

 

 

 

 

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.

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 11,000 employees within 70 facilities in 18 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 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.

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 ~70% of the drugs approved by the FDA in 2016.

For more information, please visit www.criver.com.


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

Basic Qualifications
Requirement