PharMEDium Services, a subsidiary of AmerisourceBergen, is a growing outsource compounding organization servicing hospitals nationwide.
This hands-on employee will be responsible for management and maintenance of critical systems in the aseptic filling environment as well as scheduling all facility and equipment maintenance and repairs. Must be aggressive in approach and provide feedback to Center operations personnel and strong leadership/initiative are key ingredients. Be able to work in a demanding environment and manage small scale projects and timelines. This person must have experience supervising a team of non-exempt employees. Primary Duties and Responsibilities
Qualifications: Experience and Educational Requirements
- Responsible for the management and maintenance of critical systems in the aseptic filling environment.
- Also responsible for sanitization of the clean room.
- Schedules and coordinates facility and equipment maintenance and repairs.
- Supervises the staging, labeling, and packaging, in accordance with standard operating procedures and established policies and methods to meet production commitments.
- Responsible for the continuous development of process improvements and efficiencies.
- Works on problems of moderate scope where an analysis of the situation or data requires a review of identifiable causes.
- Exercises judgment within defined procedures and policies to determine appropriate action.
- Acts as advisor to teams and becomes actively involved as required to meet schedules or resolve problems.
- Frequently interacts with subordinates, internal/external customers, and functional peer groups at various management levels.
- Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules etc.
- Provide general or direct supervision to skilled non-exempt employees.
- Assigns duties and follows-up on employee performance.
- Must be able to work a flexible schedule to support a 24/5 manufacturing environment
- Bachelor's degree in pharmacy, business or science field is preferred
- Must have 5 years hands-on supervisory experience in management of production operations in an FDA regulated or pharmacy environment, preferably aseptic drug manufacturing
- Must understand CGMP!
- Must have working knowledge of Chapter 211 guidelines for FDA
- Strong decision making skills with regards to financial impact, regulatory and legal issues, customer retention and patient safety
- Must be able to demonstrate strength in communication, leadership and problem solving skills
- Must be able to manage staff in assigned area of the facility
- Must be able to work in a demanding environment and manage small scale projects and timelines
- Lean manufacturing and Six Sigma problem solving skills preferred