Quality Assurance Auditor 1

Quality Assurance Auditor 1


Quality Assurance Auditor 1

Details of the offer

For 70 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, well help you build a career that you can feel passionate about.

Job Summary 13;

We are seeking a Quality Assurance Auditor 1 for our Biologics Testing Solutions site located in Malvern, PA.

Perform audits of basic records and reports and inspections of routine processes to assure compliance with applicable regulatory requirements, international standards, and corporate policies and procedures.

The following are responsibilities related to the Quality Assurance Auditor 1 position:

:Perform GMP data and document (SOPs, protocols/batch records) reviews to assess that records follow ALCOA+ and are in compliance with all applicable regulations, international standards, and corporate policies and procedures.
:Provide Quality Assurance support to Operational laboratories including, but not limited to: room clearances, product and raw material inspections and release, training, and facility inspections.
:Participate in development of corrective and preventative actions and process improvements in response to client and regulatory audits.
:Perform all other related duties as assigned.

The following are minimum requirements related to the Quality Assurance Auditor 1 position:

:Education: Bachelors degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.

:Experience: 1:2 years experience in a QA role or an equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed herein and above.

:Certification/Licensure: None.

:Other: Knowledge of Microsoft Office applications (e.g. Word, Access, Excel). Must be able to comprehend regulations and guidance documents and apply critical thinking skills to evaluate requirements. Must be detail oriented and able to effectively communicate verbally and in writing.

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.

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  • Auditor - Accounting - Finances / Audit - Internal Auditor



  • Basic

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