Quality Assurance Specialist II

Quality Assurance Specialist II Req ID #:  192454 Location: 

Rockville, MD, US, 20850 Rockville, MD, US, 20852 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 Quality Assurance Specialist II is responsible for supporting Quality Systems, including investigation/deviation management, CAPA tracking, Effectiveness Verification, change control, internal and external audits. This position will facilitate the compiling, trending (as required), and reporting key quality metrics for management, and other quality system functions, as needed. Continuously monitor systems and procedures to ensure compliance with applicable regulatory and industry standards, quality improvements, and efficiency for phase appropriate GMP manufacture of biological products. 

Duties and Responsibilities

•    Establishes and maintains Investigation, Deviation, CAPA, EV systems, and internal and external audit. This task includes collaborating with cross-functional departments to ensure timely implementation and closure of quality records

•    Provides guidance and advice on methods, procedures, standardization, and requirements associated with these systems.

•    Responsible for tracking and trending (as required) aspects of the Quality System and provide reports to management identifying risks and trends on a routine basis.

•    Performs CAPA effectiveness evaluation based on quantitative and qualitative measurements.

•    Administers the Change Control process for the site and conduct effectiveness verification for changes implemented.

•    Maintains tracking mechanisms to support various Quality Systems elements and ensures visibility throughout the organization.

•    Continuously monitors and review systems and procedures for adherence to regulatory compliance, quality improvements, efficiency, and industry best practices. Provide compliance support and expertise for QA department.

•    Compiles and reports site monthly corporate Quality metrics

•    Supports the Quarterly Management Review (QMR)   

•    Supports audits (internal, external) to verify the regulatory requirements, internal and CRL procedures and quality requirements have been met. Prepares annual audit plan, conducts the audit per the schedule, writes the relevant audit reports and keeps CAPA monitored to ensure compliance with the applicable regulations.

•    Supports Deviation system and ensure proper investigation and root cause analysis are performed.

•    Supports CAPA/EV system to ensure proper corrective actions are implemented and effective.

•    Supports Change Control system to ensure proper change and impact assessments are performed and tasks are implemented.

•    Develops, implements, and delivers training content for Deviation, CAPA, EV and Change Control processes and procedures.

•    Responsible for procedure reviews and facilitating procedure updates for the Deviation, CAPA, EV and Change Control systems.

•    Assures that personnel are adequately trained in the principles, policies, and procedures of the Deviation, CAPA, EV and Change Control systems.

•    Identifies and escalates compliance gaps across quality systems.

•    Maintains customer complaint and suspect sample management system and ensure its implementation

•    Additional duties as assigned.

  Job Qualifications  

•    BS required; MS preferred in scientific/technical discipline. 

•    5+ years of experience in a GMP environment

•    Strong knowledge of GMP, SOPs and quality system processes.  

•    Excellent organizational skills and ability to review and update processes or procedures.

•    Proficient in MS Word, Excel, Power Point, Adobe Pro, and electronic quality management systems. Previous experience in TrackWise, Pilgrim is preferable 

•    Certification from American Society for Quality on certified quality audit is a plus

•    Experience in pharmaceutical or bio-pharmaceutical field.

•    Education or training in cell culture and gene therapy manufacturing environment is a plus.

•    Proficient in drafting and completing technical documents and presentations.

•    Expertise in document management processes.

•    Works on multiple assignments in collaboration with various department system owners.

•    Quality systems demonstrated knowledge in areas such as Deviation, CAPA, EV and Change Control system management practices/strategies.

•    Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/600/820, ICH and EMA).

•    Demonstrates basic understanding of training, instructional design, communication and/or education.

•    Demonstrates knowledge and understanding of pharmaceutical manufacturing and quality assurance, aseptic and packaging processes, and product transfer.

•    Demonstrates presentation skills with the ability to conduct training sessions.

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.  Our main priority is the wellbeing, health, and safety of our people. We require 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 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 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 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, 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

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