Quality Ops Specialist III

Req ID #:  146699
Location: 

Baltimore, MD, US, 21224 Baltimore, MD, US, 21224 Baltimore, MD, US, 21201

At Charles River, we are passionate about improving the quality of people’s lives. When you join our global family, you will help create healthier lives for millions of patients and their families. 

 

Charles River employees are innovative thinkers, who are dedicated to continuous learning and improvement. We will empower you with the resources you need to grow and develop in your career. 

 

As a Charles River employee, you will be part of an industry-leading, customer-focused company at the forefront of drug development. Your skills will play a key role in bringing life-saving therapies to market faster through simpler, quicker, and more digitalized processes. Whether you are in lab operations, finance, IT, sales, or another area, when you work at Charles River, you will be the difference every day for patients across the globe.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   


 

Job Summary

 

We are seeking a Quality Ops Specialist III for our Life Science Hub located Hanover, MD.

 

The following are responsibilities related to the Quality Ops Specialist III:

 

•    Review manufacturing Batch Production Records (BPRs) and associated supporting documentation including logbooks, Quality Control (QC) testing reports, environmental monitoring reports, etc.
•    Perform line clearance and provide general manufacturing support
•    Supports product shipment and receipt of returns
•    Support raw material review and disposition
•    Review Building Management Systems reports
•    Participate in departmental and cross-functional continuous improvement efforts
•    Consistently set a high standard for quality of work
•    Promote a safety mindset through daily actions and communication with team members
•    Issue BPR and labels to Manufacturing.
•    Serve as owner of assigned nonconformances, CAPA, change controls, or other quality system documents and collaborate to drive completion
•    Review and approve documents in Master Control
•    Prepare lot packages for disposition decision by management
•    Train Level 1 as required
•    Other duties as assigned
 

Job Qualifications

 

The following are minimum qualifications related to the Quality Ops Specialist III position:


•    Minimum of a bachelor’s degree.
•    Minimum of 4 years GMP related experience in biopharmaceutical/ pharmaceutical or related industry.
•    Experience with GMP regulatory requirements.
•    Ability to multi-task effectively.
•    Excellent written and verbal communication skills.
•    Ability to prioritize daily activities in order to meet client needs within established time lines in a fast-paced environment.
•    Proficient in computer system use, including but not limited to Microsoft Office (Word, Excel, Power Point).

 

 


IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 
 

About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.  
 

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 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: Baltimore

Job Segment: Biotech, CAPA, Pharmaceutical, Operations, Science, Management, Research