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 I for our Biologics Testing Solutions site located in Wayne, 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.
ESSENTIAL DUTIES AND RESPONSIBLITIES:
- 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.
MINIMUM QUALIFICATIONS:
- Bachelor’s degree (B.A./B.S.) or equivalent, preferably in a life science or related discipline.
- 1-2 years experience in a QA role.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: None.
- 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.
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.
Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition ([email protected]) 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.