Quality Control Analyst II, Biomarkers - (Job Number: 0805341)

Quality Control Analyst II, Biomarkers - (Job Number: 0805341) DescriptionCentocor Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Research Scientist, Biomarkers, located in Radnor, PA. Centocor Research and Development, 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. ResponsibilitiesReview processes and data generated from Biomarker GLP studies (including raw data, technical, and validation reports). Ensure the accuracy and completeness of department documentation and compliance to all SOPs in studies and reports. Participate in audits of facilities and studies while interacting with bioanalysts to improve processes and maintain GLP compliance. Assist in preparing materials for audits by PDQA and regulatory authorities. Develop processes for a thorough and efficient review of Watson/LIMs data. Contribute to development of SOPs. The successful candidate will: Audit all GLP-related raw data to lab notebook to final reports Ensure compliance with all SOPs Complete Corrective Action Plans and follow up to ensure compliance with the plan Assure the timely archival of Department Documentation Participate in the audit of companies being considered as external vendors by Biomarker R&D. Maintain the highest level of GLP compliance Conduct audits of laboratory functions e.g., equipment logbooks, assay methods, etc. Ensure compliance with all SOPs Interface with external departments, e.g. PDQA, R&D Archive, etc. Qualifications B.S. in Biological Sciences and 5-8 years of relevant experience; or M.S. in Biological Sciences or other related field and 2-5 yeras of relevant experience. Related Experience: Work in Biotechnology FieldIf 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