Alphanumeric is hiring a SUPPORT ANALYST with supply chain in a pharma company experience to work in Cambridge, MA with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.
The Senior Deviation/Investigation Writer is responsible for performing GxP investigation activities and owning and authoring deviation investigation reports for the Supply Chain Department. The Senior Deviation/Investigation Writer will coordinate with suppliers to investigate non-conforming materials and manage supplier corrective action requests (SCAR).
- Perform investigation activities and writing deviation investigation reports for the Supply Chain department.
- Coordinate prompt event evaluation, investigation, closure and follow-up of process/equipment discrepancies and related areas as well as identify opportunities for continuous process improvements.
- Write concise and accurate investigation reports.
- Generate supplier corrective action requests (SCARs), and work with suppliers to investigate and close non-conforming material investigations
- Utilize various root cause analysis, analytical and problem-solving tools to determine root cause of GxP deviations and assist with the completion of impact analysis and identification of appropriate corrective actions to prevent recurrence.
- Participate in determining the appropriate corrective and preventative actions (CAPAs) after the investigation process.
- Update, author and review standard operating procedures and other controlled documents as a result of process improvements and CAPAs.
- Initiate Change Controls as required for Supply Chain.
- Collaborate with SMEs from other departments to ensure a cross functional evaluation is completed and ensure alignment of GxP practices.
- Perform other related assignments and duties as required and assigned
- Strong attention to detail and Strong technical Writing skills
- Must build & maintain relationships w/ Vendors, team members & other depts
- Conduct formal investigations
- Manage the Corrective Action plans
Education and Experience:
- Requires a bachelor's degree, preferably in a scientific discipline, with a minimum of 3-5 years of experience in a pharmaceutical or related industry.
- Demonstrate a sound understanding of cGMP's, FDA regulations, and pharmaceutical manufacturing/packaging processes.
- Minimum of 3 years manufacturing or technical experience in a regulated GxP environment.
- Experience in troubleshooting, investigation, and root-cause/analytical/problem-solving capabilities in a GxP environment.
- Demonstrated, strong technical writing skills with the ability to read, comprehend, and communicate complex, technical events in a manner that is concise, clear, and accurate.
- Working knowledge of Track Wise, SAP or similar deviation management system.