Quality Assurance Specialist 3

Quality Assurance Specialist 3 Req ID #:  161102 Location: 

Hanover, MD, US, 21076 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 Assurance Specialist 3 for our Life Science Hub located Hanover, MD.

The QA Specialist 3 contributes to completion of milestones associated with specific projects, clients, and supports ongoing quality assurance responsibilities in support of manufacturing operations (development and full production). Acts with minimal supervision to determine methods and procedures on new assignments Perform all responsibilities in accordance with company policies, procedures, and federal regulations.

The following are responsibilities related to the Quality Assurance Specialist 3:

1.    Provides training and coaching to QA Specialists 1 and 2.

2.    Proposes and participates in continuous improvements to applicable standard operating procedures and electronic systems related to Quality Assurance Operations Processes.

3.    Creates and reviews documents including Standard Operating Procedures, label specifications, and Batch Production Records.

4.    Represents Quality as Subject Matter Experts for Client specific projects.

5.    Reviews Batch Production Records and prepares Batch Disposition Packages.

6.    Performs “Quality on the Floor” audits and provides QA support during production.

7.    Writes Quality Assurance generated non-conformance investigations and executes CAPA plans as they relate to QA Ops process and system improvements. 

  Job Qualifications  

The following are minimum qualifications related to the Quality Assurance Specialist 3 position:

1.    Minimum of 5 years GMP related experience in biopharmaceutical/pharmaceutical or related industry.

2.    Experience with GMP regulatory requirements.

3.    Experience with electronic systems, e.g. MasterControl, LabVantage, Blue Mountain.

4.    BS/BA Life Sciences or related field.

5.    Excellent written and verbal communication skills.

6.    Ability to exercise judgement with defined procedures and practices to determine appropriate action. 

7.    Ability to prioritize daily activities in order to meet client needs on time of established timelines in a fast –paced environment.

8.    Ability to monitor and report on assigned tasks, goals and objectives. 

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. 

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 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 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 - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, 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: Baltimore

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