Project Planner QC

Location: Germantown, Wisconsin, US | Department: Quality

About the role

The Project Planner - QC is accountable for driving results by supporting QC leadership for assigned tasks, and ensuring completion of project and testing deliverables to meet customer standards, satisfaction, and timelines. The Project Coordinator - QC has a strong understanding of Sterling services with the ability to effectively interact and communicate directly with cross-functional technical teams, project managers, and external suppliers and customers. This role includes directing project activities, assignment of QC testing activities, tracking project status, and serving as a point of contact for QC information requests. The position requires knowledge and use of Sterling electronic systems and processes for project management, ability to engage with multi-disciplinary project teams, meeting standards in a GMP environment, managing multiple and sometimes competing priorities, attention to detail, results orientation, and outstanding verbal and written communication skills.

Responsibilities

• Works collaboratively with internal teams to facilitate all testing assignments.
• Upload data, reports, and other pertinent document packages to internal and external fileshare servers.
• Supports timely completion of open actions identified in meetings and follows-up with the appropriate party to drive resolution.
• Monitors QC based readiness items in support of manufacturing.
• Supports project managers for inter-site and external shipping of customer samples and product, including submission into the shipping schedule.
• Reviews forecast and pending items to ensure target revenue and invoicing dates are aligned with schedule and communicates updates and issues with the appropriate QC leadership and/or project manager to ensure timely resolution.
• Tracks and prepares metrics for QC KPIs used internally.
• Monitors incoming materials and samples, testing status in the laboratory, and communicates status to the appropriate teams to ensure timely resolution.
• Internally coordinates testing that occurs across multiple sites and/or supports manufacturing at Sterling.
• Coordinates and organizes shipments for testing required at external contractor laboratories.
• Monitors and tracks information and requirements of QC programmatic activities such as release testing, manufacturing in-process testing, stability and reference standard management to communicate with QC leadership to ensure timely execution and resolution of any issues, communicating status with key internal and external customers.
• Serves as main point of contact for the PMO and internal / external customers for all QC project related activities and issues.
• Partners with QC leadership to implement improvements to the QC workflow processes and systems.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

Associates degree required, bachelors degree in business, technical or scientific discipline preferred. Up to 2 years of related pharmaceutical or analytical laboratory experience required. Prior project management and/or CDMO experience preferred.

Skills

• Understanding of Sterling services within the QC department as it relates to customer contracts/deliverables.
• Excellent written and verbal communication skills.
• Detail orientated.
• Ability to manage multi-disciplinary project teams; prior demonstration of experience preferred.
• Awareness or prior work experience in a GMP environment preferred.
• Ability to answer impromptu questions and provide real-time updates.
• Superior organizational skills and efficiency at updating and maintaining multiple files in a variety of systems.
• Ability to manage multiple and often competing priorities.
• Proficient in computer systems including Microsoft Office programs.

Travel

Up to 5% travel required.