Position Summary:
The Investigation Writer, Deviations is responsible for the initiation, investigation, and writing of assigned deviations and associated corrective actions, preventative actions, and change control documents. The incumbent will be expected to gather data from various sources across the organization in order to lead and perform Root Cause Analysis to determine the most likely cause of the deviation and identify corrective and preventive actions to reduce deviation recurrence.
Job Responsibilities:
- Partner with an interdisciplinary team that includes but is not limited to quality assurance, quality control, operations, engineering, maintenance, calibration, safety, supplier quality, technical services, subject matter experts, and quality approvers to ensure appropriate and timely determination of scope, potential product impact, root cause, and corrective and/or preventive actions
- Author and manage several investigations simultaneously to meet key timing commitments, with well-investigated and well-documented deviation reports
- Determine appropriate corrective and preventative actions to prevent recurrence of the deviation
- Initiate change management procedures when necessary based on the outcome of investigation
- Interact will all levels of staff and provide status updates as well as present the strategy for closure of deviations
- Must be able to write for the educated but uninformed reader, translating difficult and complex scientific events into a brief and cohesive report
- Interact with both internal and external customers addressing comments
- Participation in Management meetings to update leadership on current deviation statuses
- Perform other duties as assigned
Required Skills:
- Ability to manage multiple ongoing projects concurrently
- Strong technical writing capability
- Be action oriented
- Be compliance minded while performing investigations
- Must have a thorough understanding of the pharmaceutical manufacturing process and equipment, current Good Manufacturing Practices (cGMPs)
- Must have good analysis, troubleshooting, and investigation skills
- Must have good technical writing skills
- Familiarity with Veeva Vault is preferred
Education and Experience Requirements:
- BA/BS in Science, Biology preferred
- Minimum of 2 years of Microbiology experience, Pharmaceutical Microbiology preferred
EOE, Including Disability/Veterans.
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