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International Biopharmaceuticals discovers, develops, manufactures and markets products that power the immune system to help people with serious, unmet medical needs. The company has a broad product portfolio and significant research capabilities focused on developing and commercializing novel vaccines and antibody-based therapies that prevent and treat infectious, autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, ITP and nicotine addition. Description: The QA Specialist position will be responsible for the QA oversight of the manufacturing process and areas in our Boca Raton facility. The QA Specialist contributes to overall planning, especially regarding clinical operations and marketed products. It reviews Batch Production Records (BPRs) and Standard Operating Procedures (SOPs), Deviations, EDRs, Change Control, OOS, Lookback and NCMR documentation, and may also review and approve buffer preparation records. It also reviews, processes and approves lookbacks,reviews,revises and processes product specification changes, and assists in the preparation and review of Certificates of Analysis. Background/ Education: A High School diploma is required. A BS degree in Chemistry, Biochemistry, Microbiology, Immunology, or other related technical fields is preferred. A minimum of 1 to 3 years experience in the pharmaceutical, biotechnology or medical device industry is preferred. Excellent writing and communication skills are essential to the job function, as is the ability to discuss fundamental technical and regulatory issues within a multidisciplinary environment. This is a third shift position. Please send your resume to: [EMAIL PROTECTED] Ph: 305.944.3294 ext: 100 FAX: 305-944-3712 [EMAIL PROTECTED]
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