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Space Systems Engineering - Biomanufacturing - NV
Description:
This position is primarily responsible for management and completion of site investigations. This position is an individual contributor role that works cross-functionally to collect information used to assess impact, identify root cause, and mitigate recurrence. This position requires attention to detail, organization, multi-tasking, and comfort interacting cross-functionally with people who might be junior or senior to the incumbent. The successful candidate is able to work under the appropriate amount of direction based on level and possesses the ability to work on complex problems by analyzing procedures and data to create solutions.KNOWLEDGE, SKILLS, AND ABILITIESTo perform this job successfully, an individual should be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required: Strong knowledge of cGMP regulations and the ability to apply them to commercial manufacturing. Skill in effective verbal and written communications. Ability to respond quickly to complex inquiries from customers, co-workers, and supervisors regarding deviation details. Demonstrated conflict resolution skills in a cross-functional setting with the ability to keep objectives on track. Proven technical writing skills within a cGMP manufacturing environment are required. Formal Technical Writing certification is strongly preferred. Knowledge of and skill in using computer software and hardware applications. Proficiency with Microsoft applications, including MS Word, MS Excel and Teams (required), and with eQMS applications such as TrackWise (preferred). Demonstrated ability to work collaboratively to accomplish deadlines and objectives. Demonstrated ability to work in a fast-paced environment, with the ability to manage multiple projects and objectives for on-time event closure. Ability to be proactive, detail-oriented, and adapt to changing priorities. Biotech industry experience strongly preferred EDUCATION and/or EXPERIENCE BS in scientific discipline such as Bioprocess Engineering, Biochemistry, Chemistry, Biology or related discipline Experience with quality management system (MasterControl, TrackWise, etc.) software preferred Experience interacting with clients in a Contract Development and Manufacturing Organization (CDMO) preferred Years of Experience Requirements Senior Specialist: Minimum 8 years’ experience in quality management systems, conducting investigations and/or root cause analysis working in a regulated or cGMP environment preferred Equivalent education and experience may substitute for stated requirements. Powered by JazzHR
Company:
Nova Space
Posted:
May 23 on The Resumator
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More About this Listing: Space Systems Engineering - Biomanufacturing - NV
Space Systems Engineering - Biomanufacturing - NV is a Engineering Engineer Job at Nova Space located in United States. Find other listings like Space Systems Engineering - Biomanufacturing - NV by searching Oodle for Engineering Engineer Jobs.
Space Systems Engineering - Biomanufacturing - NV is a Engineering Engineer Job at Nova Space located in United States. Find other listings like Space Systems Engineering - Biomanufacturing - NV by searching Oodle for Engineering Engineer Jobs.