Our client is seeking a Quality Control Project Specialist who will be responsible for developing and executing demand of Quality Control related activities associated with the testing and release of product within QC onsite. The scheduler will verify availability of the Quality Control Team for all oncoming projects, work with internal and external customers to conduct workload assessments to help plan the Quality Control testing schedules and deliverables timelines, and project priorities to avoid project conflicts. Additionally, the Scheduler will provide direct support to Quality Control personnel with instrument vendor management for scheduling of PM, Calibrations and instrument repair.

Essential Functions:

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Collect and analyze information used to plan and schedule Quality Control projects.

• Generate forecasts, variances reports, and other documentation used to monitor and manage all QC projects.

• Evaluate current procedures and recommends changes to improve the efficiency of planning and scheduling of projects and the reduction of issues due to scheduling errors.

• Understand and utilize standard planning and scheduling methodologies and tools.

• Prepare plans and schedule for routine release testing, non-routine testing, method validation activities, and method transfer for QC projects.

• Able to provide written and verbal analysis of schedules

• Build and update schedules for projects.

• Calculate man-hour and dollars expended and forecast and reporting

• Documentation for change order preparation, as needed

• Maintain collaborative relationships with Manufacturing, Quality, Validation, and Facilities to ensure QC testing schedules support required deliverable timelines

• Maintenance to assure the complete scope of planning activities remains connected with other tangential business operations and compliant with Quality requirements

• Periodic review of systems within the scope of laboratory testing and data generation/maintenance for all of Quality Control

• Monitor PM/Calibration due dates for lab equipment and close out WO’s in a timely manner

• Schedule vendor visits for PM’s, calibrations and equipment repair for QC equipment

• May serve as a task owner for lab investigations, CAPAs or Change Controls related to OOT’s, commissioning and decommissioning of analytical equipment

Minimum Education, Experience, Skills:

• Bachelor’s Degree required

• 3-5 years of Quality related experience required

• Prior Biopharmaceutical Planning & Scheduling experience preferred

• Experience in working in a cGMP Manufacturing Environment

• Prior experience with SAP preferred

• Proficiency in Microsoft Project, Word, and Excel

• Excellent organization and communication skills

• Strong project management skills are essential

• Must have the ability to multi-task and coordinate workload by priority

• Must be customer service and quality-oriented