Lead Batch Record Review and Release Technician

at  Thermo Fisher Scientific

KNOWLEDGE

• Understanding ‘why’ and not just the ‘how’ of processes and practices
• Knowledge of Quality practices and cGMP regulations and other international health authority guidelines
• Tech transfer experience is a plus
• Experience with investigational writing software system is a plus (Track Wise) along with root cause analysis tools utilized in deviation investigations

SKILLS

• Analytical, critical thinking, and problem skills
• Strong written and oral communication skills
• Strong math skills
• Strong attention to detail
• Strong Microsoft Office skills (especially Word and Excel)
• Solid time management and organization skills

ABILITIES

• Able to understand and carry out instructions
• Effectively multi-task
• Able to work effectively in an environment of change
• Able to work independently

PHYSICAL REQUIREMENTS / WORK ENVIRONMENT

• Lifting < 50 lbs. Walking, sitting, focus on computer screen for long periods. Repetitive hand motions.
• Able to gown, wear PPE, and work successfully in a clean room environment

• The QA Batch Disposition technician is responsible for execution of batch record disposition at the St. Louis facility.
• This individual will work closely with the Product Quality Lead team to ensure timely and compliant release of batches. The incumbent must be an excellent communicator, collaborative and possess the ability to make sound, time-sensitive decisions.
• Execute quality review and closure of executed production batch records – facilitating corrections and deviation initiation.
• Works collaboratively with manufacturing, QC, and cross-functional stakeholders to ensure deliverables are met.
• Serve as QA approver/author for SOP revisions, quality investigations, and other required site documentation.
• Associates Degree with 2 years of experience

or

• Bachelors of Science with 0 years of experience.
• Cleanroom manufacturing experience is a plus along with a comfort level with full ISO 5 and ISO 7 gowning requirements