| Sr. Capa Investigator, Cleveland, Mississippi at Cleveland, Ohio, USA |
| Email: [email protected] |
| From: Yogesh Sharma, StellentIT [email protected] Reply to: [email protected] Sr. Capa Investigator Cleveland, Mississippi Phone + Skype Job description: Summary The Investigation Owner is responsible for developing and performing the investigation, identifying the root cause(s) of the event, and documenting the results of the investigation. The IO may also assist in identifying the appropriate actions to mitigate or eliminate the root causes, and in determining an Effectiveness Plan for the actions (including effectiveness criteria and timeframe). Essential Duties and Responsibilities. This section contains a list of five to eight primary responsibilities of this role that each account for 5% or more of the work. The incumbent will perform other duties as assigned. Develop the Investigation Plan and present the Investigation Plan and results at stage-gate review. (High CA only). Determine the Define/Measure/Analyze elements of the investigation. Determine scope of the investigation. Assume ownership and lead the Investigation phase of a CAPA. Identify appropriate/cross-functional team members and assemble the Investigation Team. Confirm corrections/containment identified based on the investigation results. Identify and employ appropriate investigation tools. Determine the appropriate data sources to be evaluated for the investigation, and obtain the required data Investigate the root cause(s) of the issue. Clearly document the investigation results. Communicate the investigation results to Ensure investigation follows the CAPA procedure, including all data entry requirements per the checklists. Ensure the Investigation record is maintained with current and accurate information throughout its lifecycle. Collaborate with Action Owner/CAPA Owner to develop the Action Plan/Effectiveness Plan. Document Action Plan. Document Effectiveness Plan, including acceptance criteria and timeframe/number of opportunities. Qualifications. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. N/A: Intern or Co-op Understand strategies and be able to invent new methods or new avenues of investigation. Thorough knowledge of applicable CAPA procedures, specifications, regulations and standards. Strong analytical and problem solving skills. Good communication and leadership skills. Good interpersonal/communication/influencing/negotiation skills. Good project management skills. Working knowledge of FDA regulations and application of Good Manufacturing Practices. Education and/or Experience. Include the education and/or experience that is necessary to perform the job satisfactorily. N/A: Intern or Co-op Bachelors degree (in science or engineering preferred) or equivalent experience. 2+ years of experience in Quality, Manufacturing, Engineering or related field Keywords: California Colorado |
| [email protected] View all |
| Wed Oct 11 00:59:00 UTC 2023 |