Perform manufacture of cell culture products in accordance to current good manufacturing practices.
Monitor and ensure all personnel are following safe practices and SOP’s.
Calibrate/operate semi-automated and automated manufacturing equipment.
Weigh, measure and check raw materials to assure batches manufactured contain proper materials and quantities.
Maintain Quality Records in compliance with regulatory requirements, GMP’s and standard operating procedures.
Perform in-process testing to assure batches meet specification.
Maintain equipment and rooms in proper operation condition and proper cleanliness requirements.
Perform activities in controlled environment up to and including classified clean room conditions.
May be required to perform other related duties as required and/or assigned.
Nature and Scope
Identifies and solves problems using defined procedures and policies. Works independently on new and existing assignments by following existing procedures. Performs routine assignments independently; uses standard protocols to determine methods and procedures for routine assignments. Receives general direction on new assignments.
*Minimum Qualifications (must have)
Minimum of 3-4 years of manufacturing experience in a GMP Manufacturing environment or a combination of education and experience.
Requires a high school diploma.
Works in a manufacturing environment; is required to lift up to 45 lbs. and may be required to stand for long periods of time while performing duties. Must be able to work safely with materials and equipment. Must be able to work overtime and flexible shifts. Various levels of gowning are required.