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What you will do
Lets do this. Lets change the this vital role you will be a key member of the team that develops and facilitates training and the Human and Organizational Performance (HOP) philosophy in the Amgen North Carolina Biologics Drug Substance Manufacturing plant. We are looking for a talented Manufacturing team member to help deliver opportunities for reliability efficiency agility and differentiation for the ANC Manufacturing plant.
This individual contributor position reports into the Senior Manager of the MFG Technical Training team and interacts broadly across the site to implement key training and (HOP) deliverables quality initiatives. This role will focus on supporting manufacturing training on and off the floor and supporting investigations when necessary. The flexibility to support all four shifts covering 24/7 operations is a requirement.
Supporting the development and execution of the manufacturing training strategy ensuring operational readiness and efficient time to contribution.
Providing training expertise for MFG area of responsibility (i.e. cell culture purification MFG Services).
Leading and organizing MFG New Hire Orientation ensuring content is up to date and relevant.
Performing Job Task Analysis on the floor to determine where Performance Supporting Materials (SOP updates videos one-slide updates etc.) are needed and then creating Performance Supporting Materials to create a best-in-class training program.
Supporting Manufacturing teams during complex investigations and change controls.
Use operational Learning Team strategies to promote open collaboration with staff to maximize learning opportunities and investigation findings.
Support annual requalification programs for manufacturing to ensure training compliance.
Maintain accurate Training Assignment Profiles and Assignment Vehicles for Manufacturing areas.
Serve as Learning Management System SME and first stop for questions from MFG staff and management about the training program.
Present complex topics to large and small groups at various levels and quickly understand and clearly communicate complex issues.
Build effective relationships across functions.
Navigate through ambiguity and provide a structured problem-solving approach.
Additional Qualifications/ResponsibilitiesBasic Qualifications:
High school diploma / GED and 10 years of Manufacturing or Operations experience OR
Associates degree and 8 years of Manufacturing or Operations experience OR
Bachelors degree and 4 years of Manufacturing or Operations experience OR
Masters degree
Preferred Qualifications:
5 years related work experience (manufacturing process development or quality assurance) in biotech or pharmaceutical industry with progressively increasing responsibility
Experience in training development and facilitation
Training content creation expertise in systems
SOP writing & technical writing skills
Experience working in Learning Management Systems
Degree in Science or Engineering
Experience using Quality Management Systems (i.e. Track Wise or Veeva) for Deviation investigations and CAPAs
Demonstrated project management ability
Experience presenting to inspectors during regulatory inspections and internal audits.
Excellent written and verbal communication skills
Ability to work in a team matrix environment and build relationships with partners
Strong interpersonal skills
Salary Range
92002.00 USD - 108605.00 USD