Aseptic Technician II JR00007553
Position Summary
This Aseptic Technician II position is responsible for executing department specific tasks in accordance with all applicable cGMPs and compliant with Corporate/site procedures, regulations and policies.
Seed: Supply and provide seed for all areas of ABI. Produce and maintain sufficient supply for production needs. Keep accurate inventory records of current seeds.
Position Responsibilities
- Execution of aseptic techniques and clean room procedures or support area procedures in a GMP facility.
- Maintain and edit, as appropriate, departmental cGMP documentation.
- Execute and lead operation to comply with all written procedures, to include Batch Records and SOPs.
- Follow and comply with all financial procedures.
- Follow and comply with all site safety procedures. Identify ways to improve the safety culture of the department.
- Operation of departmental equipment to include set up and take down. Provide oversight as necessary.
- Effectively work in a team environment and communicate with multiple departments.
Seed:
- Perform environmental monitoring and staging of clean rooms.
- Perform accurate cell counts.
- Manipulate roller bottles or operate and maintain bioreactors for seed production.
- Monitor and respond to BMS (Building Management System) alarms.
- Accurately document production activities on paper and in computer based systems.
- Perform inoculation, candling, and harvest of all CEO seeds.
- Update and revise SOPs and MDs
Education and Experience
- High school education or GED required.
- Post High School education in the Sciences or other related disciplines preferred.
- Previous experience in a manufacturing environment and / or Operator I level beneficial.
- Good mathematical, science and computer skills preferred.
- Demonstrated teamwork and collaboration skills required.
- Strong communication skills required.
- Demonstrated leadership and decision making skills beneficial.