Investigations Lead Specialist
vor 1 Tag
At Randstad Staffing, we are committed to creating an inclusive environment where diverse backgrounds, perspectives and experiences are valued. Our commitment to respect the dignity and diversity of all is embedded in our values.
Job DescriptionThe Non-conformance Investigator position aims to follow the overall process of non-conformance investigations, based on Johnson & Johnson requirements. The investigator will be responsible for the E2E investigation process: initiation, lead and writing of impact assessment, leading execution of the investigation of Medium/High Impact Non-conformances, aiming at the identification of assignable and/or root cause, as well as implementation of corrections, Corrective and/or Preventive Actions to prevent Recurrence, and effectiveness check.
Main Responsibilities:- Independently lead non-conformance issuance, performance of impact assessment and respective investigation to prevent recurrences in support of Manufacturing operations.
- Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the non-conformance investigation, identification of Corrections and Corrective and Preventative Actions to reduce or prevent recurrence.
- Routine interaction with the Operations, Quality Control, Quality, Assurance, and other departments to communicate investigational status, perform alignment meetings, facilitate reviews, CAPA discussions and comments resolution.
- Technical writing of investigation reports for the educated but uninformed reader, that accurately capture immediate actions and containment of the event, conclusion on the cause of the non-conformance and follow-up actions to prevent recurrence.
The successful candidate will have a strong background in biopharma production environment regulated by cGMP standards, preferably in manufacturing operations and/or Quality Control. Additionally, they should be skilled in supporting pharma process investigations, experienced in Root Cause Analysis tools (e.g. 5 Why, Fishbone, Kepner-Tregoe) and technical writing.
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