The manufacturing investigation team (MIT) is a component of Bulk Manufacturing Operations and provides direct support to Manufacturing. The function of MIT is to support continuous improvement activities and compliant Bulk Manufacturing Operations by responding to and investigating process deviations; designing effective CAPA; developing and delivering successful training; and monitoring and measuring ongoing performance of Bulk Manufacturing quality systems. MIT staff collaborates with Bulk Manufacturing and Quality Assurance management and staff to assess issues and drive for continuous operational improvement.
Using expert knowledge of manufacturing process to thoroughly investigate deviations to procedures and specifications
Driving investigation process to successful resolution through close collaboration with Manufacturing and Quality teams
Determining accurate root causes of problems
Proposing and implementing effective CAPA to eliminate these causes
Implementing defined training programs and on-the-job training modules
Working with Quality Training Staff and Manufacturing Management to develop staff knowledge and proficiency in compliance and oversee delivery of training program
Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities.
Following accurate oral & written procedures in execution of GMP job functions Monitoring operations to ensure compliance with process specifications
Practices safe work habits and adheres to Genzyme s safety procedures and guidelines
Works independently with minimal supervision and direction. Participates in determining objectives of assignment. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.
Project manage each deviation to ensure it meets its 30 day deadline
Point of contact and owner of deviations/CAPA/Change Control
Investigate and identify root cause
Determine long-term and short-term corrective actions (CAPA)
Works closely with QA and Management to address comments
Participate in cross-functional team meetings to resolve deviation issues
Facilitate weekly deviation meeting and provide status updates on all open deviation
Interview individuals involved with the event
Updating SOPs or other official documents as required
Possibility of investigating events in the suite
Hold facilitated meetings to ensure timely closure of a deviation, if required
If deviation requires a change control and/or CAPA, the lead investigation is the owner and takes responsibility for completion
Contacts outside vendors if applicable
Skills:Bachelor s or Associate s Degree with 3-5 years experience in a CGMP regulated Biologics or Pharmaceutical environment or equivalent experience.
Subject matter expertise in either Cell Culture, Protein Purification or Support Services. At least 1 year experience with deviation or investigation management systems
Education:Bachelor s Degree
Relevant industry Biotechnology Manufacturing and/or Quality operations experience. Training, coaching, leadership experience
Experienced authoring and reviewing standard operating procedures, on-the-job-trainings, and other controlled documents
Expertise with Deviation Management Systems (i.e. Trackwise).
Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment
Ability to gown and gain entry to manufacturing areas.
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Last updated on Oct 14, 2015