Core Qualifications:

• Bachelor's degree in Engineering, Biology, Chemistry, or a related field.
• 1-3 years of relevant cGMP compliance experience in manufacturing or pharmaceuticals.
• Proven experience in project management, process excellence, and quality operations in a pharmaceutical environment.
• Proficiency in Microsoft PowerPoint, Excel, Word, and Visio.
• Knowledge of GMP, quality assurance processes, and manufacturing practices.

Key Responsibilities:

1. Collect and analyze data through observation of tasks and processes.
2. Develop current state process maps for identified areas.
3. Organize and coordinate meetings for data and process evaluation.
4. Identify improvement opportunities and collaborate with area managers and QLT to develop proposals.
5. Propose new process workflows based on evaluations.
6. Develop and implement plans for procedural updates and necessary training.
7. Establish metrics for monitoring process improvements.
8. Execute improvement plans and track progress.

Required Skills/Abilities:

• Strong problem-solving skills, with the ability to identify deviations and recommend solutions within established practices.
• Ability to manage multiple projects and prioritize tasks efficiently.
• Excellent written and verbal communication skills.
• Ability to build collaborative relationships across departments and work well in a team environment.
• Detail-oriented with a strong focus on process improvement and capacity analysis.
• Self-directed with strong organizational and time management skills.

Position Requirements:

• A combination of relevant education, training, and experience will be considered for this position. Familiarity with project management tools and quality assurance methods is essential.