22 days old

Project Coordinator

Kelly Services
Fremont, CA 94536
**Job Description**

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 Bio-pharmaceutical 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 bio-pharmaceutical 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.


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

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.


minimum one (1) year work experience in cGMP regulated industry, more than one year preferred.

minimum High school diploma required.

Project coordination experience preferred.

**Why Kelly** **** **?**

At Kelly
Services , we work with the best. Our clients include 95 of the Fortune
100 companies, and more than 70,000 hiring managers rely on Kelly annually to access
the best talent to drive their business forward. If you only make one career connection today, connect
with Kelly.

**AboutKelly Services** ****

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people
around the world and have a role in connecting thousands more with work through our global network of
talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
Posted: 2019-07-29 Expires: 2019-08-29

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Project Coordinator

Kelly Services
Fremont, CA 94536

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