Batch Record Coordinator

Fremont, CA

Contract Duration: 12-24 months

Rate: Negotiable

Salary: NA $1.00

Responsibilities:

• Excellent employment opportunity for a Batch Record Coordinator in the Fremont, CA area.
• Works with Schedulers, Process Order Creators, and Operations to forecast and manage process orders and batch records according to the detailed manufacturing schedule.
• Focuses on coordinating on-time batch record release and delivery.
• 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 Fremont for key inputs and for reporting outputs.
• Ensures that all metrics, issues, and commitments are managed and resolved in a timely manner to aid overall success for Downstream Manufacturing Operations.
• Ensures Process Order Planners create all Process Orders needed for each campaign.
• Ensures Document Management Services Writers draft and deliver Paper Batch Records on-time for Downstream Manufacturing processing.
• Ensures BioMES Electronic Batch Record (EBR) Modelers draft EBRs on-time for Downstream Manufacturing processing.
• Maintains detailed Batch Record Delivery Schedule & Tracker for each product campaign in collaboration with Process Order Creators, Process Sciences, PTTO, Product Subteams, and Project Managers.
• Develops and implements process order management best practices.

• Minimum of One (1) Year: GMP work experience in cGMP regulated industry, more than one year preferred.
• Minimum: High School Diploma required. This position requires intermediate understanding of Biopharmaceutical Manufacturing, especially in the use of Batch Records.
• Requires strong organizational skills and advanced interpersonal skills.
• This role has significant cross-functional duties from within the manufacturing organization.
• Involves moderate level of decision making at the task execution level.
• High degree of independence required for task coordination and monitoring of production 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.