6701 Kaiser Drive Fremont, CA 94555
Bayside Solutions is seeking a PO Coordinator to be part of our client’ s team in the East Bay. This is an opportunity to work with one of the largest Biopharmaceutical companies in the world developing innovative medicine to improve the quality of patients’ lives.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Works with Schedulers, Supply Chain, 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. 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.
- This role 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 BI Fremont for key inputs and for reporting outputs. This role ensures that all metrics, issues, and commitments are managed and resolved in a timely manner to aid overall success for Downstream Manufacturing Operations.
- Ensures Supply Chain Management Planners create all POs 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.
- Develops detailed Batch Record Delivery Schedule & Tracker for each product campaign in collaboration with Supply Chain, Process Sciences, PTTO, Product Subteams, and Project Managers.
- Collaborates 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.
- Designs, coordinates, and executes minor process order projects. Coordinator formalizes all key inputs, requirements and parameters into a short-term, detailed delivery schedule.
- Develops and implements process order management best practices.
- The PO Coordinator is responsible for coordinating the release and printing of process orders and batch records for manufacturing activities in Drug Substance. This role is cross functional, collaborative, and dynamic requiring a basic understanding of Biopharmaceutical manufacturing processes. The PO Coordinator maintains strong lines of communication with Upstream and Downstream Operations, Production Scheduling, Engineering & Technology, Quality, and Supply Chain.
- This position requires intermediate understanding of biopharmaceutical manufacturing and business systems, process flows, controls, and timelines. Requires strong organizational skills and advanced interpersonal skills. This role has significant cross-functional impact to 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.
- Minimum one (1) year work experience in cGMP regulated industry, more than one year preferred.
- Minimum High school diploma required.
- Project coordination experience preferred.
- 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.
- Ability to work as part of a high performing team and collaborate effectively with staff.
- Ability to concentrate on detail-oriented work in a complex technical setup with a Quality and Right the first time mindset.
- Good IT & ERP skills including: MS Project, MS Excel, MS Visio, MS Word, SAP, and BioMES.