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Deviation Management Specialist - III (Experienced)

Company:
LanceSoft INC
Location:
West Point, Pennsylvania, United States
Posted:
December 05, 2016
Description:

Qualifications:

A B.S degree in Chemical, Mechanical, or Bio-Engineering, Biological Sciences, or related disciplines is required. Demonstrated interpersonal skills including flexibility and ability to work in a team environment. Proven analytical abilities. Demonstrated leadership and teamwork skills, experience managing and motivating teams, excellent analytical abilities, proven written and verbal communication skills. More than one (1) year post- bachelor’s degree experience in technical development or other engineering/scientific functions (can be obtained through a combination of post-graduate education and work related experience). Candidates should have strong interpersonal skills, verbal and written communication skills, and scientific problem solving skills. Previous experience in the pharmaceutical industry is preferred but not a requirement. This position is for 1st shift (8AM -5PM).

Responsibilities:

Responsible for investigation of manufacturing deviation events occurring during the manufacture of vaccine products. Specifically, will lead the investigation of atypical events to determine the root cause. Will develop corrective actions to prevent reoccurrence, and will assess the impact of the deviation on product quality. Technical leadership will be required to ensure that vaccine product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective. Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report. Responsible for investigation of these deviations (both minor and major), with key responsibilities to interface with floor operations, their coordinator (direct manager), and other key stakeholders and subject matter experts.