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Quality Assurance Specialist I - Raw Material Release

Charles River Laboratories International Inc (CRL)

Rockville, MD, US, 2085

Quality Assurance Specialist I - Raw Material Release Req ID #:  213231 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20850 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.

 

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  

 The QA Specialist I – Raw Material Release will support the Quality Assurance department by releasing raw materials, components, consumables for use in Manufacturing and Quality Control Labs.  

 

 

Key Responsibilities and Duties:

 

•     Review and approve Material Specification and Disposition documents

•    Review, evaluate, and approve test results to disposition materials for use in manufacturing or testing

•    Author, review and approve SOPs as it pertains to Material Specification and Disposition

•    Perform material release to ensure compliance with CGMP regulations

•    Perform material receipt 

•    Review Quality Control data

•    Support the management of retain program

•    Review material and equipment logbooks

•    Review and approve deviations, CAPAs, and change controls

•    Track and trend raw material release data for Quality Metrics

•    Revise SOPs as required to ensure procedures are compliant

•    Identify process and system improvements

•    Keep management informed on concerns/issues 

•    Review logbooks

•    Assist with reviewing batch records, QA on the floor duties as needed

•    Additional duties as assigned Job Qualifications  

•    BS/ BA in life sciences or related fields. 

•    Minimum 4 years of experience in GMP related experience in biopharmaceutical/ pharmaceutical or related industry, preferably 2 years of experience in releasing raw materials. 

•    Ability to multitask effectively. 

•    Previous knowledge and experience with the practical implementation of FDA, EMA and ICH regulations and guidelines. 

•    Exceptional interpersonal skills including the ability to influence behaviors and negotiate and resolve challenges with poise, tact, and diplomacy. 

•    Strong verbal and written communication skills.

•    Strong organizational skills; able to prioritize and manage through complex processes/projects. 

•    Ability to define problems, collect data, and draw valid conclusions. 

•    Ability to organize and disseminate information efficiently and multi-task in a fast-paced environment, organized, responsible, creative, pays attention to detail, multi-tasker. 

•    Knowledge of Microsoft suite (Word, Excel, Access, Vizio and PowerPoint). 

•    The ability to follow instructions and Standard Operating procedures. 

•    Ability to always maintain a professional and pleasant demeanor. 

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 Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

 

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 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 86% of the drugs approved by the FDA in 2021.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

 

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: Washington DC

Job Segment: Quality Assurance, Pharmaceutical, Laboratory, Biotech, Technology, Science, Research

Job posted: 2022-12-06

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