Technical Manufacturing Associate I
• Responsible for executing aseptic processing in a clean room environment adhering to Standard Operating Procedures.
• 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.
• Process production batches in a LFBSC.
• Responsible for filling vials ranging from .2mL to 60ml.
• Responsible for filling bottles ranging from 100 mL to 1L.
• Responsible for filling sterile bags ranging from 250mL to 20L.
• Responsible for final product packaging of bottles, bags, vials (boxing).
• Responsible for completing assigned tasks (for example, cleaning, lab setup etc.) related to departmental functions.
• Perform preventative maintenance and general upkeep on equipment and facilities including environmental monitoring.
• Responsible for reviewing SOPs, MBRs and other associated forms for revision; Revise SOPs, Batch Records or other documentation as needed.
• Review and sign manufacturing batch records.
• Assist in training entry level staff members.
• Being available for business necessitated overtime is required.
• Perform other duties as assigned.
• *This position primarily encompasses with the various roles (Vialer, assistant, perform environmental monitoring) in the cleanroom to fill bulk media into bottles, bags, vials; Most employees spend the majority of their day in a cleanroom environment*.
• Must be able to lift 50 pounds repeatedly and stand for long periods of time.
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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