Manufacturing Technician I - Cleanroom GMP | Temp to Hire

Title: Manufacturing Technician Location: San Clemente, CA Duration: Temp to Hire 1 st shift: 6:00AM - 2:30PM 2 nd Shift: 2:30PM - 11:00PM Position Overview Perform the following tasks: Perform kitting operations (measure out components or raw materials) Ability to perform activities under a microscope Prepare components and build device assemblies Prepare bulk drug formulations Perform filing, capping, and crimping operations Perform packaging and labeling operations Perform sampling Perform visual inspections Perform documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR) Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality management system (QMS) medical device good manufacturing practices (GMP) requirements. Additional tasks as required Responsibilities Maintain proper cleanroom environment (including gowning, room cleaning, and supplies) Follow, execute, and adhere to documentation in accordance with cGMP, QMS, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), batch records (BRs), device history records (DHRs), and engineering batches. Perform basic calculation and data entry Assembly, disassembly, and cleaning of process equipment Clean, etch, passivate, assemble, and inspect components Process and assemble components in accordance with documented specifications and procedures Prepare bulk drug formulation operations Perform filling, capping and crimping operations Perform packaging and labeling operations Perform in‑process inspection of assemblies and finished products in accordance with specification criteria Organize and clean the work areas Perform validation and qualification activities (IQ/OQ/PQ/PV) Work Experience 0 – 2 years of related experience in the medical device, pharmaceutical, and/or biotechnology industries Desirable experience working in and maintaining a cleanroom in accordance with GDP and cGMPs standards Education High School Diploma Required We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options. TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce. #J-18808-Ljbffr