Senior/Principal GMP Investigator
- Employer
- Intarcia Therapeutics
- Location
- Hayward, California
- Salary
- Not Specified
- Posted
- Feb 24, 2017
- Closes
- Mar 26, 2017
- Ref
- 2712164027#GIJ--J2CBackfill.1
- Category
- Claims
- Job Type
- Not Specified
- Career Level
- Not Specified
Job Description The Senior/Principal GMP Investigator (2 separate roles) is primarily responsible for leading complex issue resolution for the Commercial Global Operations department at the Hayward, CA site to deliver exceptional business and regulatory results. In this role, you will work with the appropriate cross functional teams to drive resolution of complex GMP investigations for Hayward and external manufacturing/suppliers. As the Senior/Principal Investigator, you will be expected to take a methodical approach in root causes analysis and identifying the appropriate corrective and preventive actions. Principal Investigator: In addition to your primary responsibility as an investigator, you will have an opportunity to define and shape the scope and responsibilities over time. You must be able to propose strategic goals by gathering the quality and operations needs; identify and evaluate trends and options and determine appropriate course of action. You will provide facilitation, training, guidance and support to drive process improvements using Lean/Six Sigma/Kepner-Tregoe methodologies. As the Principal Investigator, you will be responsible to lead design of tools, systems or trainings which will improve investigations approach, align with industry best practices and standards and maximize compliance and operational effectiveness. You will partner with the functional leaders to identify, prioritize and drive improvement projects. You will also provide the necessary training, facilitate and lead Kaizen sessions as the business requires. Senior Investigator: You will provide facilitation, training, guidance and support to drive process improvements using Lean/Six Sigma/Kepner-Tregoe methodologies. As the Senior GMP Investigator, you will be support development tools, systems or trainings which will improve nvestigations approach, align with industry best practices and standards and maximize compliance and operational effectiveness. You will partner with the functional leaders to identify, prioritize and drive improvement projects. You will also provide the necessary training, facilitate and lead Kaizen sessions as the business requires. You are exceptional in investigation writing and have a solid understanding of GMP and compliance requirements. You enjoy providing clarity and thrive under highly complex and ambiguous situations. Strong leadership, collaboration, analytical, negotiating, influencing and communication skills are key for success in this role. A Can-Do attitude is a must. Duties/Responsibilities: Resolve highly complex GMP investigations (root cause analysis and CAPA) with high quality standards and in a timely manner Lead, facilitate, coach, mentor and provide technical expertise root cause analysis and improvement initiatives Conduct regular Gemba Walks in key areas to identify gaps for further improvement and foster a Continuous Improvement culture Proactively learn, develop, share best practices and customize new methods and techniques (Lean/Six Sigma, Agile, Design Thinking, Change Management) to improve effectiveness of issue resolution Develos, maintain and monitor key performance metrics Act as an internal consultant/advisor for deviations, root cause analysis and issue resolution.Qualifications Bachelor of Science (Science related discipline) Principal Investigator: >10 years hands on experience (Engineering, Operations, QC or Quality) in pharmaceutical cGMP environment. Proven leadership skills managing project teams with successful results Senior Investigator: Minimum of 2-5 years hands on experience (Engineering, Operations, QC or Quality) in pharmaceutical cGMP environment Demonstrated track record in resolving highly complex GMP investigations Experience and track record in effectively leading complex issue resolution Proven ability to communicate clearly and present key information objectively and collaborate effectively with management. Proven leadership skills managing project teams with successful results Kepner- Tregoe, Lean/Six Sigma Greenbelt or Blackbelt Certification highly desired