Job Description

Job Title: Visual Inspection Operational Lead(RAMP Operations)

Location: Concord, NC

Duration: Long-term Annual Contract (with potential to convert full-time)

Position Overview:

The Visual Inspection Operational Lead (RAMP Operations) is a key position responsible for supporting the ramp-up of new Parenteral Operations at our Raleigh site. This individual will collaborate closely with the Visual Inspection Process Team (PT) to ensure successful startup, operational readiness, and the transition to routine production. The role involves implementing best practices, overseeing operational readiness, and driving continuous improvements while fostering a collaborative, cross-functional environment.

Key Responsibilities:

Operational Readiness and Support:

• Drive Best Practices: Role model and promote habits aligned with the Manufacturing System of Excellence (MSOE) for the process team.
• Problem-Solving: Identify and address batch-related challenges resulting from missing or poorly designed processes.
• Documentation: Create standard work documents, process maps, and other tools to ensure right-first-time execution and long-term sustainability.
• Consultation: Advise on best practices for managing work orders, deviations, change controls, and related processes.
• Ramp-Up Support: Assist the site with operational readiness, including shop floor setup, business processes, and training for the transition from APS to routine production.
• Metrics and Performance Review: Establish key metrics, review line performance, and mitigate human errors during the ramp-up phase.
• Cross-Functional Troubleshooting: Act as a point of contact for troubleshooting and escalation, working closely with various teams (e.g., Project Team, GPP, etc.) to resolve issues.
• Resource Planning: Liaise with central functions and the RAMP/Acceleration team to ensure adequate resource allocation during the ramp-up phase.

Leadership and Communication:

• Facilitate Workshops: Lead or participate in workshops, such as After Action Reviews and lessons learned, to drive continuous improvement.
• Communication and Collaboration: Ensure clear and consistent communication between the site, RAMP team, and broader network, sharing learnings and best practices across sites.
• Mentorship and Development: Support the development of the site’s operational teams, fostering a culture of mentoring, coaching, and feedback.

Continuous Improvement and Special Projects:

• Participate in or lead initiatives aimed at continuous improvement, including the development and assessment of cross-functional proposals.
• Contribute to the growth of the site’s capabilities through collaboration with various teams to ensure operational efficiency.

Basic Qualifications:

• Bachelor’s degree or equivalent experience.
• Proven experience in a GMP (Good Manufacturing Practice) facility.
• Proficiency with computer systems, including Microsoft Office products.
• Strong written and verbal communication skills, with the ability to interact effectively across all levels of the organization.
• Experience in mentoring, coaching, and providing feedback.

Preferred Qualifications:

• Previous experience with Lilly M&Q operations.
• Experience in Production, QC, QA, Technical Services, Engineering, or Regulatory.
• Knowledge of cGMP (current Good Manufacturing Practices).
• Technical writing and communication skills.
• Six Sigma Green Belt or Black Belt certification.

Additional Information:

• Overtime: May be required based on operational needs.
• Travel: 30-50% travel may be required to support other sites during the ramp-up process.

Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.

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