Technical Operations - Senior Manufacturing Technician Job Description:The candidate for this position will be responsible for assisting in inhalation products manufacturing for use in clinical studies. He/she will perform routine tasks with little supervision necessary to maintain and clean equipment and facilities for the manufacture of clinical supplies. A major part of this position will be the execution of the Environmental Monitoring program. Other duties for this position are:
Perform routine manufacturing operations for the production on clinical batches and operate production equipment according to SOPs.
Maintenance and cleaning of production equipment.
Execute Environmental Monitoring program
Maintain stock of clean room supplies
Understand operations and contact appropriate support to ensure issues are appropriately resolved.
Identify process deviation and take immediate action to mitigate event. Daily organization and cleanliness of work area to comply with regulatory requirements, GMPs and SOPs.
Accurately maintain GMP documentation (batch record and logbooks throughout production area).
Assist with writing and editing SOPs, and maintenance of production equipment.
Addition of this position to company's staff is vital to support Tiotropium Bromide HFA MDI and Fluticasone /Salmeterol HFA MDI clinical trials planned for 2012.