Discovery Quality Specialist

Req ID #:  148431
Location: 

Worcester, MA, US, 01608

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 an experienced Discovery Quality Specialist for our Discovery site located in Worcester, MA

 

Responsible for independently managing the site’s Discovery quality systems. Will also help to implement new systems for the site, often in conjunction with the Business Optimization group.  Assist with development of special projects, initiatives and strategies that support operational excellence, quality, client service, growth and mitigate business risk.  


 
Successful candidates in this position will:

  • Help to facilitate the design, implementation, and management of the site’s Discovery quality program.  This may include creating/revising written guidelines, implementing systems, monitoring effectiveness and compliance, providing training/mentorship, and hosting client visits. 
  • Identify process improvement opportunities impacting productivity, turnaround time, quality, and business risk.
  • Lead site special projects by providing thoughtful leadership and oversight from conception to completion.  This may include developing project timelines, budget, and providing guidance and direction to senior leadership and cross-departmental teams and devising ways to track project outcomes.
  • Pilot new and innovative processes/procedures/software for use by Discovery business units. 
  • Create, revise, and/or review applicable documents and procedures for assigned projects.
  • Assess project risks, identify problems/challenges, and provide solutions where applicable.
  • May lead departmental teams and working groups to achieve desired outcomes.
  • Prepare and present project status updates and strategic advice to senior management and other internal audiences. 
  • Network with experts at other sites around the organization to establish and share best practices and templates for the benefit of the company.  
     

Job Qualifications

The following are minimum requirements related to the Discovery Quality Specialist position.

 

Education:  Bachelor’s degree (B.S./B.A.) preferably in a life science, or equivalent.
Experience: Minimum of 5 years of relevant work experience working in the CRO/Pharmaceutical industry.  Experience working in a FDA regulated facility and knowledge of GLP and 21 CFR part 11 regulations 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: No specific certifications or licensure required.
Other: Demonstrated ability to create and revise SOPs, / BOP’s, policies, guidelines, software validation documents, etc. Demonstrated project management skills and ability to deliver results. Demonstrated ability to innovate and to effectively lead and communicate at all levels Computer literate and proficient with basic Windows applications. Experience with Smartsheet highly desirable. Must be able to pay strong attention to detail and communicate issues effectively and professionally. Ability to work effectively as a member of a team, demonstrate leadership, and facilitation skills. Ability to work in a dynamic, fast-paced, and detailed driven environment
 

Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 320 patents and 74 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.


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 18,000 employees within 100 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 supported the development of >80% of the drugs approved by the FDA for the past 3 years.


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 crrecruitment_US@crl.com. 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.


Nearest Major Market: Worcester

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