Manufacturing Operations Associate
Newark Metro Area, NJ
Ability to work in an aseptic environment requiring successful completion of qualification program.
Support cell therapy production campaigns:
o Execute established batch records in ISO 7 & 8 clean room environments.
o Observe, practice, and promote all aspects of the GMP & GDP requirements.
o Maintain aseptic processing and sterile gowning qualifications.
o Communicate with Quality Control to ensure proper handoff of process samples.
Maintain laboratory and equipment for cleanliness and compliance.
o Complete room activity, maintenance, cleaning, and equipment usage logs.
o Run daily calibration checks on equipment where appropriate, and escalate deviations.
o Perform daily, weekly, and extended cleaning of laboratory areas and equipment.
Assists with development of Standard Operating Procedures (SOPs) and/or production batch records associated with new processes that are transferred from Development into Manufacturing Operations
Interact with Supply Chain, Facilities, and Development as needed to ensure smooth operation.
Reports and initiates non-conformances, and participates in follow up investigation when necessary.