Responsible for cleaning and sanitizing fill rooms, sterile storage, and various equipment per current Standard Operating Procedures (SOP) and current Good Manufacturing Processes (cGMP). Must be knowledgeable of and practice good aseptic technique to minimize potential for product contamination.
PRINCIPAL ACTIVITIES PERFORMED:
Practice aseptic technique at all times while working in sterile areas.
Documents work accurately and timely.
Complies with current SOP’s and cGMP’s.
Cleans and sanitizes all sterile production areas according to SOP’s.
Assists in cleaning and sanitizing equipment (tools, filling machine equipment, carts, etc.) as needed.
Unloads ovens and autoclaves when cycles are completed and verified.
Loads components into ovens from sterile side as required.
Monitors sterile uniform supply and maintains an adequate inventory.
Assists in cleaning and checking Lyophilizers as needed.
Perform other duties as assigned.
High school diploma or equivalent.
Basic mechanical aptitude.
Ability to follow policies and procedures.
Completes documentation accurately and timely.
Demonstrates good Oral communication skills.
Demonstrates teamwork skills.
Able to follow direction.
Excellent attendance and punctuality.
Able to lift 20-30 pounds.
Able to work with Antineoplastic products.
Able to stand for long periods of time.
Able to maintain gowning requirements and practice good aseptic technique.