Preferred Qualifications:
Educational background in Life Science and/or Engineering
Written and Verbal communication in English and Spanish
In-depth experience in Root Cause Analysis (Fishbone Six Boxes Fishbone 5 Why s)
Supply Chain experience (receiving suppliers warehouse shipping)
Strong Technical Writing Skills
Skilled in performance of GMP operations
Compliance/Regulatory knowledge and interaction experience
Experience leading cross-functional teams for RCA and problem solving
Ability to communicate and collaborate with technical and management staff within manufacturing process development supply chain and quality.
Strong presentation skills.
Project management skills.
Specific responsibilities include but are not limited to:
Complete Root Cause Analysis
Apply Process Expertise capable of understanding process and controls require to assess for potential causal factors
Assess process performance by observation of floor operations and review of performance data.
Support trouble shooting to identify Causal Factors and potential corrections
Evaluate operational procedures
Evaluate training requirements for technical aspects of the process
Identify training opportunities
Use and perform Risk Assessments as required to identify and understand risks and failure modes
Define CAPAs
Evaluate process improvement opportunities
Negotiate Actions with Partners
Deliver timely robust plan to address Root Cause
Perform Impact to Process /Equipment /System Assessment
Team with Product Development to understand potential impact to product quality attributes
Assess Equipment/Systems information for potential impact to product quality attributes
Assess for Data Integrity
Assess for Process Validation Impact
Author Investigation Report
Use Technical Writing techniques proficiently
Perform Data Verification
Ensure timely report approval
Support Peer Review
Follow current standard procedures/templates
Serve as SME to define deviation designation when called upon
Facilitate Process and Equipment Risk Assessments and make recommendations to mitigate risks
Participate in regulatory inspections
Participate in the assessment or implementation of special projects or initiatives.
Make strategic planning to support product supply and business performance metrics.