Investigator 2, Manufacturing

Major Accountabilities

• Able to work on event, minor and major investigations with applying site and global compliance SOP’s.
• Identify and address corrective and preventative actions (CAPAs) based on root cause analysis and ensure they are implemented and effective.
• Organize, participate in and/or lead cross-functional investigational teams including internal and external (client) members.
• Track and analyze performance metrics to identify trends and develop continuous improvement projects.
• Participate in Problem Analysis (PA) sessions.
• Support document revisions, review/ approval of investigation records and participate in quality improvement initiatives.
• Prepare storyboards for significant deviations and ability to present to regulatory agencies.
• Participate and/or lead difficult discussions to internal team, clients and regulatory agencies.
• Attend and participate in meetings, including tier meeting, internal and external client calls, team huddles, business review meetings, and others as needed.
• Support junior investigators regarding investigative techniques and best practices.

Minimum Requirements

• High School Diploma or Equivalent with 9 years of applicable industry experience OR Associate’s degree with 7 years of applicable industry experience OR Bachelor’s degree with 5 years of applicable industry experience OR Master’s degree 3 years of applicable industry experience
• Understanding of cGDPs and cGMPs and the requirements to operate in a clinical and commercial manufacturing environment.

Preferred Qualifications

• Understanding of operational excellence and the ability to apply root cause analysis, problem solving and continuous improvement methodology.
• Strong knowledge of Excel, Word, and PowerPoint.
• Root Cause Analysis (RCA) training.

Physical Requirements

• Ability to stand for prolonged periods of time (120 minutes).
• Ability to conduct activities using reptitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.