Prepare line/equipment to fill aseptic products, in accordance with applicable standards (e.g., cGxP, SOPs).
Planning Plan work activities in accordance with production schedule, and shifting priorities
Verify production schedule to determine & adjust activities according to production priorities
Ensure that materials needed for production is available
Coordinate work activities with coworkers Technical Clean and prepare equipment for aseptic filling operations, in accordance with standards and procedures (cGxP, SOPs, etc.)
Strictly adhere to Current cGMP, Current cGDP, and SOPs. Resolve and/or report all discrepancies immediately.
Operate Clean-in-Place (CIP) and Steam-in-Place (SIP) on fill line equipment in accordance with SOPs and quality standards.
Prepare fill line equipment for sterilization.
Perform CIP, SIP, and Flush operations for all lines.
Prepare and change out filters for aseptic and non-aseptic activities (e.g., Preventive Maintenance and sterile filtration).
Complete required documentation (MBRs, SOPs, log books, etc.) in accordance with cGMP and cGDP
Troubleshoot & fix minor aseptic problems line/equipment, alerting maintenance or supervisors as needed Team Collaborate with co-workers to meet business objectives
Share knowledge & experience with co-workers to develop team's overall capability.
Develop personal knowledge and skill, continuously learn
Adapt schedule to flexible work hours Sponsor/train coworkers who are new
Be flexible with respect to assignments, work schedules Interfaces Coordinate with other shifts and departments to ensure smooth execution of work
Communicate & work with QA on product quality issues & compliance activities
Communicate & work with Maintenance to resolve problems with equip
Exchange accurate & complete information regarding production w/ supervisor
Communicate & work with Materials Control to ensure efficient flow of materials & products
Communicate & work with Quality Control to ensure proper technique as well as good aseptic technique Safety/Housekeeping Keep work areas clean and free of hazards or dangerous conditions
Follow department & company safety guidelines
Perform duties in accordance with HSE standards
Adhere to garbing requirements in accordance with SOPs
Adhere to all Personal Protective Equipment (PPE) guidelines at all times
Participate in site safety programs
Perform routine cleaning on line/equipment & work areas
Identify & report safety hazards or unsafe behavior