QA Auditor II

QA Auditor II Req ID #:  194658 Location: 

Wayne, PA, US, 19087 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.  Basic Summary We are seeking a QA Auditor ll for our Biologics Testing Solutions site located in Wayne, PA 

Responsible for participation in Client Audits that include scheduling, preparation, and hosting the client’s visit. 

ESSENTIAL DUTIES AND RESPONSIBILITIES: Prepare and issue client audit responses, ensuring clear communication of audit findings to the auditors/auditees and relevant management. Assists in the preparation and hosting of regulatory inspections Host For Cause Audits as needed. Including the following action items: Review/Approve Write/Revise Standard Operating Procedures Work Instructions, Policies, Protocols, Reports related to Quality Provide guidance and training to staff and operational staff on quality related matters. Work closely with Site Management to provide Quality Compliance support for all areas and processes. Participate in the maintenance of overall compliance status of all GMP operations Participate in implementing key improvement initiatives and help solve compliance issues while partnering with business & process owners Contributes to the completion of organizational projects and goals Generate and tracks key performance indicators and quality metrics as requested Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures Assist in scheduling and tracking QA audits, inspections and procedures as requested. Work closely with other Biologics QA personnel on multi-site quality agreements and harmonizing processes. Performs other work-related duties as assigned.

MINIMUM QUALIFICATIONS:

  Bachelor's degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline. A minimum of 3-5 years in Quality  Working knowledge of domestic and international cGMP Regulations Familiarity with 21CFR Part 11, 210, 211 and 820 Must have strong communication skills Must have strong attention to detail Applies critical thinking to identify solutions to non-standard requests and complex problems. Ability to work in a dynamic, fast paced environment with shifting priorities Able to handle multiple tasks to meet timelines in dynamic environment.

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: Philadelphia

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