Alphanumeric Systems Inc.

Support Analyst

Cambridge, MassachusettsContract
About the Job
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).

Primary Responsibilities:
  • 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
Top Skills:
  • 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.