LanceSoft is hiring: Deviation Writer in Morris Plains

Deviation Writer
Onsite role in Morris Plains, NJ
Pay range: *** - *** based on skills and experience

To author deviations related to facilities and engineering processes, equipment, and areas. This includes the initiation, investigation, authoring, identifying correct CAPAs, and effectiveness checks of those CAPA's while meeting required timelines.

Major Accountabilities:

1. Initiate deviations within required timelines.
2. Support the facilities team in the triage of unexpected events.
3. Author investigations for facilities and engineering-related deviations within required timelines.
4. Work cross-functionally to assess deviation impact and identify root causes.
5. Use equipment/facility knowledge and root cause investigation tools to analyze data and identify root causes.
6. Work collaboratively in the design of CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
7. Support the escalation process of deviations when appropriate according to escalation guidelines. Present escalation events and provide deviation details clearly and on time (root cause and CAPAs).
8. Provide support for all internal or external audits.

Key Performance Indicators:

1. Opening and closing of deviations within required timeframes.
2. Closing of CAPAs within required timeframe.
3. Effectiveness of CAPAs.
4. Success rate of internal audits and Health Authorities' inspections.

Requirements:

Education: BSc. in Engineering or equivalent scientific degree.
Languages: Fluent in speaking/writing in English.
Experience: Minimum 3 years' experience in GMP manufacturing role with 1 year of deviation/root cause analysis experience.

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