QC Project Specialist

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Job Summary

Quality Control Scheduler position is responsible for developing and executing demand of Quality Control related activities associated with testing and release of product within Quality Control at the Emergent Bayview site. The scheduler will verify availability of the Quality Control Team for all oncoming projects, work with internal and external costumers 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

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

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

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

• Understands and utilizes standard planning and scheduling methodologies and tools.

• Prepares plans and schedules 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

• Schedules 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

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

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 essential

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

• Must be customer service and quality oriented

Physical/Mental Demands and Work Environment Characteristics

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.