This is a 2nd shift position. Hours are 1:00pm - 11:30pm with rotational weekend coverage required per business need.
Compounding of sterile and nonsterile finished products. This position requires Rinse Water Certification, Aseptic Gowning Certification, Environmental Monitoring Certification, Physical, Lock-out/Tag-out Certification, Confined Space training, and Cleanroom Certification. Assumes responsibility for the GMP, ISO, environmental health and safety procedure awareness, and compliance within the respective area.
Performs nonsterile and aseptic compounding activities per batch record documentation. Must be able to compound Level 1 and 2 batches proficiently (Level 1: simple sterile solutions; simple non - sterile solutions; Level 2: multiphase sterile solutions; multiphase non-sterile solutions, suspensions, ointments.). Must be able to perform training for Level 1 batches and activities. Document information correctly in batch records, CAMS (operator access level), and area logbooks. Review and verify batch record entries. Assist compounding of Level 3 batches.
Select and prepare major and miscellaneous compounding equipment for use. Clean equipment and perform rinse water testing.
Perform equipment sterilization.
Perform filter integrity testing. Prepare filters per compounding schedule.
Perform environmental monitoring during batches. Assist Microbiology EM technician with emergency environmental monitoring.
Perform daily and weekly scale calibration checks. Weigh materials not already pre-weighed and staged for the batch.
Clean, disinfect, and maintain the compounding area.
Maintain GMP hours and EHS training. All other duties as assigned.
High School Diploma. Excellent math skills. Detail oriented. Good communication and documentation skills. Mechanical aptitude. Able to work quickly and under pressure. Must be able to read, write, and speak English.