• Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
• Lead CAPA investigations and at times manage the implementation of CAPA.
• Own manufacturing related change controls.
• Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
• Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
• Review production documentation and perform quality walk-throughs during manufacturing events.
• Participate in continuous improvement teams such as 5s, Gemba and the *** Production Systems (GPS).
• Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
• Lead team meetings and facilitate multidepartment discussions.
• Stay current with biopharmaceutical industry best practices and technologies.
• Other duties as assigned.

Requirements:

• Bachelor's degree or equivalent experience.
• 3 years of related experience.
• Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).
• Experienced with standard troubleshooting approaches (problem statement, root cause analysis, Ishikawa (fishbone diagram), 5 Whys).
• Good computer skills, knowledge of Microsoft office products Word, Excel, Office.
• Collaborate with cross-functional teams to integrate compliance measures into various aspects within manufacturing operations.
• Ability to meet schedule is required; this position may infrequently include shift, weekend, or holiday work and overtime as dictated by a 365-day production schedule.
• Ability to work in a cleanroom environment and comply with hygiene standards and use of clean room gowning.