Drive manufacturing deliverables to ensure successful commercial operations, including:
- Review deviation investigation reports to ensure World-Class levels of quality with respect to, Compliance, Logical Flow, Simplification of the Complex, Technical Completeness and Grammar
- Provide feedback and coaching to investigation report authors
- Lead investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence by:
- Lead problem solving and root-cause analysis sessions
- Interact with Quality, Engineering and Tech Service units
- Manage complex investigations using DMAIC tools
- Ensure effective implementation of corrective and preventive actions
- Management of highly technical/visible Investigations
- Management of highly technical/visible cross functional projects
- Owner / point of contact for global initiatives / projects
- Author and revise GMP documents and manufacturing records (e.g. Batch records, SOPs, change controls, etc.)
- Train staff in general manufacturing activities
- Collaborate in the mitigation of any Environmental, Health, and Safety (EHS) needs and risks. Identify and implement improvement initiatives to improve yield, reliability, and/or process robustness. This may require leading and implementing change controls
- Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to the biopharmaceutical industry, as well as technical understanding/problem solving capability
- Stay current with biopharmaceutical industry best practices and technologies
- Responsible for organizing data and preparing appropriate documentation, including presentation materials for assigned projects.
Education and Experience Requirements
Bachelor degree required
Minimum eight years relevant professional experience required (GMP preferred). Demonstrated ability to perform in a high performing workforce.
Key Skills, Abilities, and Competencies
- Excellent technical writing skills required
- Requires strong skills related to coaching and mentoring others
- Strong problem solving and analytical skills are required.
- Must have excellent organizational, verbal and written communication skills; able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance.
- Possess knowledge of core manufacturing principles and support systems
- Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment.
- Self-driven individual that requires minimal supervision
- Must have proficient computer skills and be experienced using MS Office software (Word, Excel and PowerPoint), Trackwise.
- Prefer knowledge of Lean Six-Sigma methodology
- Prefer experience in Track-wise system.