Quality Control Associate - (Job Number: 0716868)

Quality Control Associate - (Job Number: 0716868) Description Centocor, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Quality Control Associate within the Clinical Quality & Compliance group located in Chesterbrook, PA. Centocor, Inc. develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. Under the direction of the Associate Director / Manager, Clinical Quality & Compliance, performs quality control (QC) reviews and assessments of Clinical Research activities within Centocor, and assists senior QC staff when performing activities at offsite External Service Providers (ESPs) and clinical research investigator sites. Assists with process, training, and records management activities. Specific activites include, but are not limited to: Perform QC reviews of submission documents in preparation for submission to regulatory health authorities, and other Clinical and Regulatory documents and data, as required. Perform QC reviews of Clinical Research departmental activities and processes. Assists in performing QC assessments of ESPs and clinical research investigator sites, as required. Assist personnel to develop appropriate responses to Quality Assurance audits. Perform follow-up activities as necessary. Perform and/or assist with QC projects, as assigned. Minimum of a BS degree is required. MS degree is a plus. Clinical or Scientific Discipline preferred. Minimum of 1-3 years of previous Quality Assurance, Clinical Research Monitoring, Clinical Trial Management, Data Management or Medical Writing experience. Should have a working knowledge of the drug development process, FDA regulations and guidance documents, ICH guidelines, strong oral and written skills, effective problem-solving skills and ability to orchestrate multiple activities at once in order to accomplish a goal. Must be able to travel occasionally. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now