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 | Job posted by U.S. Engineering Technical Services, inc |
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| Description | Responsible for providing critical Quality Assurance support for batch review and disposition of bulk drug substance, review of equipment validation protocols and reports, general quality systems compliance management support, and auditing of suppliers and internal groups. Essential Functions ? Batch review and disposition of bulk drug substance, with some client interface. ? Review of equipment validation protocols and reports. ? General compliance quality systems management support o Raw material and solution release o Write, revise, and review SOPs o Review MPRs o Provide guidance, review and follow up for Investigations related to Deviations, CAPA, and OOS o Assist with Change Control documentation ? Perform on site audits of vendors ? Perform internal audits of operating groups ? Lead and/or assist in Quality Improvement Projects ? Other duties as assigned by management |
| Requirements | Must be able to be flexible as workload dictates; extra support time may be required and will need to be present for manufacturing needs. ? Understanding of application of GMP principles in US and EU clinical production a must. ? Candidate should be quality conscious, self-starting, task-oriented, and independently motivated, as well as team-oriented and flexible, able to assist in other tasks when and where needed to meet Company goals. ? Exceptional organizational skills and the ability to prioritize are essential. ? Strong written and verbal communication skills a must. ? Must be proficient in MS Office. ? Exposure to EDMS/document management system a plus. ? Requires flexibility for occasional off-hours support. ? Travel requirements expected to be less than 20%. Minimum Education & Experience Requirements ? Bachelor's Degree, preferably in a scientific discipline. ? Minimum of five (5) years quality assurance experience in a GMP environment. ? GMP laboratory and/or manufacturing experience a plus. |
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This job expired on 10/02/2012
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