PO Coordinator

Fremont, CADuration: 12-36 monthsRate: NegotiableSalary: NA $1.00Responsibilities:Excellent employment opportunity for a PO Coordinator in the Fremont, CA area.Responsible for coordinating the release and printing of process orders and batch records for manufacturing activities in Drug Substance.Cross functional, collaborative, and dynamic requiring a basic understanding of Biopharmaceutical manufacturing processes.Focuses on coordinating on-time batch record release and delivery.The PO Coordinator helps Manufacturing-Logistics Coordinators to ensure on-time raw material deliveries to Downstream Manufacturing Operations.The role ensures alignment with all Quality cGMP compliance, process requirements, and campaign readiness to help ensure batch record availability in accordance with the Production Schedule.Requires attending Process Order & Batch Record meetings to track document revisions, updates, and approvals with advanced levels of information sharing and interactions among all functional groups across company for key inputs and for reporting outputs.Ensure that all metrics, issues, and commitments are managed and resolved in a timely manner to aid overall success for Downstream Manufacturing Operations.Ensure Supply Chain Management Planners create all POs needed for each campaign.Ensure Document Management Services Writers draft and deliver Paper Batch Records on-time for Downstream Manufacturing processing.Ensure BioMES Electronic Batch Record (EBR) Modelers draft EBRs on-time for Downstream Manufacturing processing.Develop detailed Batch Record Delivery Schedule & Tracker for each product campaign in collaboration with Supply Chain, Process Sciences, PTTO, Product Subteams, and Project Managers.Collaborate with Change Control owners and supports the change control process as it applies to batch record revisions, campaign readiness, and New Product Introduction (NPI) BR creation.Design, coordinate, and execute minor process order projects.Coordinator formalizes all key inputs, requirements and parameters into a short-term, detailed delivery schedule.Develop and implements process order management best practices.Intermediate understanding of biopharmaceutical manufacturing and business systems, process flows, controls, and timelines.Experience:High School Diploma required.Project coordination experience preferred.Minimum one of year work experience in cGMP regulated industry, more than one year preferred.Requires intermediate understanding of biopharmaceutical manufacturing and business systems, process flows, controls, and timelines.Strong written and verbal communication skills.Ability to work with computer-based systems and manufacturing execution systems (MES).Ability to read and understand SOPs and work instructions and the ability to document work in a written format in compliance with cGMP standards.Good IT & ERP skills including: MS Project, MS Excel, MS Visio, MS Word, SAP, and BioMES.