Operational Excellence Specialist

Role Summary

As an Operational Excellence Specialist, you will be responsible for assisting with execution of the production schedule by troubleshooting and remediating operational and process issues. It will include owning/authoring maintenance notifications and revising GMP documents such as SOPs and Manufacturing batch records.

Responsibilities

• Author maintenance notifications and assess product impact using inputs from various departments.
• Assist in investigations including root cause analysis.
• Revise and manage manufacturing documents such as Batch Records and SOPs.
• Lead rapid response for issues identified on the floor with completion of the incident form and supporting data to establish a path forward with area leadership and operational quality.
• Initiate a Quality Notification as required following the rapid response.
• Transfer all collected investigative information to the owning specialist and support additional data capture as needed.

Qualifications

• Bachelor‚Äôs degree
• 2 or more years technical experience - preferably in biopharmaceutical manufacturing processing
• Previous experience with production control systems
• Previous experience authoring and/or revising technical documents

Preferred Qualifications

• Advanced degree in Biology, Biochemistry or Chemical Engineering
• Knowledge of cGMP requirements and practices and previous experience in a cGMP setting
• Ability to work effectively cross-functionally, lead teams and implement project plans on time and on budget

Location

St Louis, MO. This is not a remote opportunity.