Title: Deviation Writer
Duration: 12 Months
Location: Morris Plains, NJ - 07950
Onsite role in Morris Plains, NJ
Description:
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 and throughout meeting required timelines.
Major Accountabilities:
Deviations, Investigations, and CAPAs:
• Initiate deviations within required timelines.
• Support the facilities team in the triage of unexpected events.
• Author investigations for facilities and engineering related deviations within required timelines.
• Work cross-functionally to assess deviation impact and identify root causes.
• Use equipment/facility knowledge and root cause investigation tools to analyze data and to identify root
causes.
• Work collaboratively in the design CAPAs and CAPA effectiveness checks to eliminate/mitigate deviations.
• Support the process of escalation of deviations when appropriate according to escalation guidelines. Present
escalation events and provide deviations details clearly and on-time (root cause and CAPAs).
• Provides support for all internal or external audits.
Key Performance Indicators:
• Opening, and closing of deviations within required timeframes
• Closing of CAPAs within required timeframe
• Effectiveness of CAPAs
• 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.
...A Professional Survey Project Manager oversees a team comprised of Survey Party Chiefs, Survey Field Crews and Technicians. This person... ...of the community. Applicant must be a Registered Professional Land Surveyor in either MS, TN or AR license or the ability to...
...Online SAT & ACT Tutor The test-taking process is often stressful, for both students and their parents. ArborBridge tutors are an elite class of educators who bring a combination of expertise, enthusiasm, and organization to their work, breaking down complex ideas...
...Who are we? We are experts in business analysis, program management, change, sustainability, process improvement, and customer experience. However, being a Clarasys consultant is not just about delivering the same thing over and over again. We ensure the work we do is...
...We are currently offering a full-time Entry Level opportunity to add to our team in support of our Social Media and Marketing efforts. We are looking to add a candidate with social media marketing experience and an analytical approach. Experience in Graphic Design,...
...comma? Are you always the person to point out a typo or spelling error? Are you ready to work with a team ofcollaborative and creativemarketing and advertising professionals? How about trying to find a place with a walk-in snack pantry full offree food? You...