Quality Specialist On the Floor - Medimmune (Philadelphia, PA) in Philadelphia, Pennsylvania For Sale
Quality Specialist On the Floor Location PA, Philadelphia (Non Sales) Job Description The QA Specialist, On the Floor, is responsible for assuring the quality of products manufactured at the PA facility. The Responsibilities include Quality at the Source utilizing on the floor real time review and investigations, auditing, change management utilizing a risk based approach, and timely decisions. QA oversight of aseptic processing. Review and understand analytical data. Process map work flows and write Standard Operating Procedures (SOPs). Reviews GMP documents such as batch records, logbooks and reports. Be actively involved in daily operations to meet schedules or to resolve complex problems. Demonstrate strong organizational skills related to priorities and work load. Position requires the ability to solve complex problems independently and within a team environment. Provides leadership to others within and outside of the QA function. Can function as back-up to Manager when delegated to do so. In addition, have ability to be a team leader. Can be delegated additional review and approval authority. Must have flexibility to work any shift. ~BSP Position Requirements Position: 3+ years of experience in biopharmaceutical/pharmaceutical industry. Experience in aseptic processing GMP experience in a QA role Education: Bachelor of Science in Biology, Chemistry, Engineering or related fields is preferred. Ability to use electronic systems such as Trackwise and SAP. Frequently use and apply technical standards, principles, theories, concepts, and techniques. Possess familiarity with the use of Operational Excellence (OE) tools/lean manufacturing; knowledge of both US and international regulatory guidelines and standards. In addition, has a working knowledge/technical base to be able to perform critical tasks and establish working plans to meet strategic vision. Must have flexibility to work any shift. Currently there are two (2) Quality on the Floor positions available. Relocation and travel expense reimbursement is not available for this position. Req ID xxxx Position Category Operations - Quality
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