Project Coordinator

Description

50% onsite required

Work Schedule: Mon-Fri(normal business hours)

Pay Rate- $37.30

Position Description:

1. Supports delivery of clinical supplies through effective management of assigned projects.Manages multiple projects. Liaise with responsible Trial Supply on aspects of clinical supplies packaging and labelling design and study requirements. Ensures production schedules meet agreed upon on-time delivery date of finished supplies. Develops detailed time and event schedules, manages and tracks all activities and milestones related to assigned projects.Responsible for coordinating availability of all deliverables (e.g. drug product and components, randomization file and label text).
2. Generates internal packaging and labeling bill of materials and productions orders in accordance with the clinical trial design and all relevant regulatory requirements for assigned projects. Responsible for the creation and/or release of Bill of Materials and process orders in SAP for assigned projects, including relevant checks on order accuracy.
3. Executes all required SAP transactions such as goods receipt and goods consumption. Assures Bill of Material structures are consistent with the requirements of Independent Requirement Order (IRO) and Packaging Specification (PS). Converts planned orders (print and production) into process orders completing all required user fields and adding long text as required. Executes TECO transaction on completed process orders.Compiles supporting documentation and delivers a body of evidence (batch records) that supports the release of finished supplies for clinical use. Liaises with Quality Assurance to secure release of finished supplies.
4. Reviews and approves vendor generated label proofs, orders specifications and other related documents. Reviews and approves vendor generated production orders and other related documents (i.e. change orders).
5. Ensures regulatory and CGMP compliance of activities in assigned areas of responsibility, through monitoring and management of performance and reporting any deviations immediately to the appropriate management and Quality unit.May enter change controls and deviations into quality management system and conduct investigations as assigned.
6. Works cross-functionally with individuals and project teams in various areas.
7. Identifies opportunities for improving business processes and/or participates on project teams that are focused on continuous improvement.
8. Participates in assigned training including CGMP and safety training.
9. Authors and reviews procedural documents.

Education:

1. Preferred Bachelors degree or equivalent in pharmacy, engineering, business or life sciences .
2. Minimum Associate degree required
3. 1 - 3 years relevant experience in the pharmaceutical industry or related healthcare environment.

Competencies Required:

1. Demonstrates ability to plan, manage and execute multiple projects and to deliver aProductst critical timelines in a fast-paced, rapidly changing environment.
2. GMP and/or clinical trial experience highly preferred
3. Strong project management skills.
4. Possesses solid oral and written communication skills.
5. Good decision making and organizational skills.
6. Demonstrates ability to effectively communicate ideas and to influence others to achieve results.
7. Knowledge of ERP/MRP systems and supply chain principles.
8. Eager to learn and continuously improve.