Requirements Education / Experience
Doctorate degree OR Master’s degree and 2 years of experience OR Bachelor’s degree and 4 years of experience OR Associate’s degree and 10 years of experience OR High school diploma / GED and 12 years of experience
• Project Management experience
• Excellent organizational skills, detail-oriented & accurate, analytical skills.
• Experience with audits and regulatory agencies.
• Ability to adhere to regulatory requirements, written procedures, and safety guidelines
• Result oriented
• Excellent mathematics skills
• Effective written and verbal communications skills
• Experience with spreadsheets and schedules
• Knowledgeable of Trackwise, SAP, EDW, Excel, Word, Power Point, Smartsheet and other analytics software
• Trackwise and SOP Management experience
• Fluent in English and Spanish
• Must be a team player, self-starter, persistent, tactful, and persuasive
• Ability to work under time pressure, and effectively in a team matrix environment.
• Availability to support non-standard shift operation and extended hours
• Ability to adapt to multiple and increasing responsibilities, priorities, tasks, and projects simultaneously.
• Ability to organize work to meet deadlines.
• Ability to safely handle, transport and/or manage hazardous materials.
• Under limited supervision, will oversee, manage, and coordinate all operational aspects of ongoing department projects impacting multiple departments.
• Serve as technical expert to cGMP operations in one or more core distribution functions(s): receiving, storing, transferring, or shipping materials per standard operating procedures or guidelines.
• Proficient use of inventory system(s) allowing staff member to resolve basic system issues within Amgen’s ERP system.
• Proficient use of multiple quality, operations and logistical software applications including SAP read, write, access, review and verify cGMP transactions.
• Provide meeting support to several cross-functional teams. Set project timelines and priorities based on project objectives and ongoing assignments.
• Create, analyze, and present metrics. Work closely with Supply Chain Operations and Planning teams to ensure product and material requirements are managed.
• Lead multi-departmental, cross-functional, multi-site projects and processes of small to moderate size.
• Identify and report operational issues and process improvement opportunities to leadership, propose solutions and assist in addressing.
• May monitor work processes to ensure compliance and successful completion of metric targets.
• Owns and reviews department’s standard operation procedures, training materials, and other GMP documents to ensure completeness and accuracy.
• Owns and documents deviation and CAPA records in Trackwise quality system.
• Tracks and reports on spend to budget. Provides input to management for cost reduction opportunities.
• Comply with safety guidelines, cGMPs and other applicable regulatory requirements.
• May participate in area investigations/ audits.
• Maintain training proficiency.
• Troubleshoot, solve problems, and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Initiate and complete routine investigation and technical tasks.
• Contributes to work group/team by ensuring the quality of the tasks/services provided by self.
• Provide department management with project management support on an as needed basis as well as for special projects.
• Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
• Provide solutions to a variety of technical problems of moderate scope and complexity.
• Manage competing timelines and prioritize critical tasks.
• Establish and achieves project standards for work quality and quantity.
• Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.
Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.
– Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
– Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
– Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
– Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
– Maintain and track project budget(s).
– Reconcile the use of resources for the projects.
– Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
– Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
– Actively participate in directing the evolution and defining the role of the project.
– Ensure the project goals and objects are well understood by the various functional areas.
– Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
– Maintain the master project plan and schedule for assigned projects.
– Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
– Provide department management with project management support on an as needed basis as well as for special projects.
– May manage and direct the activities of project support staff.
– Conduct annual performance reviews and provides career counseling and general guidance.
– Identify or lead focus area projects within the overall function of project management or related projects.
– Generate periodic updates and prepare formal presentations for required forums.
– Generate individual and more complex reports utilizing various resources.
– Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
– Ensure project work complies with practices, policies and standard operating procedures.
– Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
– Anticipate resource needs and communicate to management sponsors.
**Other functions that may be assigned.
Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience or Associate’s degree and 10 years of Project Management experience or High school diploma / GED and 12 years of Project Management experience
– Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
– Skills in working under time pressure, and effectively in a team matrix environment.
– Practical project management software and spreadsheet skills, proficient computer operation skills.
– Effective interactions in a team or matrixes environment.
– Good organizational skills, detail-oriented & accurate, analytical skills.
– Team player, self-starter, persistent, tactful, and persuasive.
– Effective verbal and written communication skills (writing and presentations).
– Ability to assume increasing levels of responsibility.