Project Coordinator QC

The Project Coordinator - 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.

• 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.
• An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

• 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.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities and activities may change at any time with or without notice.

• 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.

• Up to 5% travel required.

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