Supply Chain Production Planner

About the role

Work with various functions such as Supply and Production Planning, Procurement, MDO, Manufacturing to coordinate and execute IVDR associated activities in San Jose Reagent Manufacturing to meet the BDB IVDR program timeline and deliverables.

Responsibilities

• Create and update manufacturing documents (Specifications and procedures) and master data (BOMs and routings) impacted by the BDB EU and non-EUIVDR program. Prepare and submit ACRs and ECRs.
• Coordinate with Planning and Manufacturing to ensure manufacturing readiness of phase out of old versions and phase in of new versions of products in the implementation of labelling and packaging changes. Perform regulatory impact assessment for label change implementation.
• Work in Documentum, SAP and other document archives to gather and review available documentation. Retrieve, compile, summarize manufacturing and QC test data in reports to support IVDR Technical Document and international regulatory submissions.
• Provide data and information to support the PIM/ EuDaMed data load and ongoing maintenance.
• Perform other tasks as assigned to support IVDR and Reagent Operations.

Requirements

• Requires a Bachelor’s degree in biological sciences and 1 year of experience in a manufacturing or laboratory environment or related business/industrial experience.
• Prior experience in a FDA or ISO medical device regulated manufacturing environment and knowledge of medical device documentation, product labeling, manufacturing and business process are desirable.
• Knowledge of general laboratory safety, GMP's and associated regulatory requirements
• General knowledge of Microsoft Word and Microsoft Excel, and the ability to learn and function competently within SAP software environment.
• Requires good documentation (maintaining clear and concise records) and effective communication

Qualifications

• The preferred candidate will demonstrate excellent organizational skills, and the ability to manage multiple/changing priorities and effectively work in a team environment.