SD/SEV & Aseptic Finished Goods Manager

Job description:

General Requirements

This position will require the employee to fulfill the following general requirements for employment at Stallergenes Greer and includes but limited to:

• Practice good hygiene and personal sanitation practices
• Compliance with applicable standard operating procedures
• Compliance with company environmental health and safety procedures
• Protect and preserve Stallergenes Greer physical property and equipment
• Protect and preserve Stallergenes Greer intellectual property and confidential information

pecific Job Requirements

This position requires the following for employment at Stallergenes Greer and includes but not limited to:

Job Task(s)

• Manage the daily manufacturing activities of the sterile filling operations for Allergy extracts and SD/SEV
• Coordinate scheduling of routine activities and tasks to personnel to effectively meet production timelines.
• Ensure batch documentation is completed according to appropriate GMP standards.
• Check inventory and orders supplies as necessary based on schedule.
• Communication of issues within Department and with Cross Functional Departments.
• Ability to present metrics within Department and with Cross Functional Departments including Senior Leadership.
• Effectively communicate schedule or process changes to affected personnel in a timely manner.
• Investigation of Events, Deviations, Out of Specifications, etc…
• Implement process improvements through Lean Six Sigma tools, 6S, CAPA, Change Controls, etc…
• Complete Change Requests and revision of documents
• Keep track of technician’s training/qualifications to ensure they are up to date
• Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements
• Interviews, hires, coaches, motivates, develops, recognizes and manages performance of direct reports
• Assign performance objectives and development plans, monitor progress and provide regular feedback to all direct reports
• Other Job Duties as Assigned