What are the responsibilities and job description for the Media Manufacturing Associate - Walkerville, MD position at Unicon Pharma Inc.?
Title: Media Manufacturing Associate
Job Description
Responsible for performing production functions in Powder or Liquid Media manufacturing facility according to company and departmental SOP’s. Individual will maintain records to comply with Good Manufacturing Practices and Standard Operating Procedures. Individual will work in a fast-paced, safety-oriented, team environment.
Work Schedule: Regular Office Hours; May have a need to work rotating manufacturing schedule based on project/Business need.
Job Description
- Responsible for executing aseptic processing in a clean room environment adhering to Standard Operating Procedures
- Set up and operate production equipment
- Complete documentation concurrently with completion of manufacturing processes
- Responsible for performing personal and environmental monitoring
- Be able to gown aseptically and work in an aseptic environment
- Perform cleaning of production tanks and associated equipment
- Responsible for formulation of bulk productions and stock solutions
- Process production batches in a LFBSC
- Perform integrity testing on all sterilizing filters
- Wrap and assemble filling materials in preparation for autoclaving
- Performs material transfer activities, such as deboxing, disinfectant of cleanroom materials, and transfer for staging
- Assist in drum filling operations when required
- Responsible for completing assigned tasks (for example, cleaning, lab setup, etc.) related to departmental functions
- Ensure general upkeep on equipment and facilities including environmental monitoring
- Review and sign manufacturing batch records and other documentation
- Responsible for keeping current on all job relevant trainings
- Maintain accurate production bin inventory in responsible area.
- Provide information related to deviations to support investigations
- Being available for business necessitated overtime is required
- Perform other duties as assigned.
Quality:
- Adherence to established procedures is required at all times during manufacture and testing.
- All personnel own the quality of what they deliver and are responsible for notifying responsible management in a timely manner of deficiencies, process deviations, product defects and related actions.
- Individual is expected to be competent and professional during all written and face-to-face interactions with peers internal and external to the Media Manufacturing team
Safety
- Follows safety protocols; ensures personal and team safety in working area.
- Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries.
- Must comply with safety policies of the company and site.
Skills
- Questioning attitude to drive problem solving
- Ability to collaborate with cross-functional teams
- Ability to communicate effectively to share learning and provide training to manufacturing