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TEMP--Manufacturing Tech II (Pilot Ops), 1st Shift

Location
San Clemente, California
Job Type
Permanent
Posted
15 Oct 2020
Job DescriptionThe Manufacturing Technician (I, II, III, Lead), based in San Clemente, CA you will be responsible for the following: Prepare components and build 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 and/or track clean room, environmental chambers, and equipment preventive maintenance (PMs) Perform all activities with good documentation practices (GDP) in accordance with current good manufacturing practices (cGMPs) and quality system regulation (QSR) medical device good manufacturing practices (GMP) requirements. Responsibilities: Ability to follow, execute, and adhere to documentation in accordance with cGMP, QSR, and GDP requirements: protocols, specifications, work instructions (WIs), standard operating procedures (SOPs), BRs, and DHRs Ability to perform basic calculation and data entry Ability to assemble, disassemble, and clean process equipment Ability to clean, etch, passivate, assemble, and inspect components Ability to process and assemble components in accordance with documented specifications and procedures Ability to prepare bulk drug formulation operations Ability to perform filling, capping and crimping operations Ability to perform packaging and labeling operations Ability to perform in-process inspection of assemblies and finished products in accordance with specification criteria Ability to perform validation activities (IQ/OQ/PQ/TMV/PV) Ability to perform routine equipment preventative maintenance (PM) Ability to coordinate with approved vendors the daily/weekly/monthly/quarterly additional activities, collect vendor certificates, and complete documentation Work Experiance: 3-6 Years Experiance To be successful in this role, you will need to have the following industry (medical device, pharmaceutical, and/or biotechnology) and educational experience. It is highly desirable to have experience working in and maintaining a clean room in accordance with GDP, cGMPs, and QSR standards Education: High School Diploma About UsGlaukos Corporation is an ophthalmic medical technology and pharmaceutical company focused on the development and commercialization of novel surgical devices and sustained pharmaceutical therapies designed to transform the treatment of glaucoma, one of the world's leading causes of blindness. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, in order to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent®, its first MIGS device, in the United States in 2012 and is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale injectable therapies designed to address the complete range of glaucoma disease states and progression. The company's second-generation MIGS device, the iStent inject® Trabecular Micro-Bypass System, was approved by the Food and Drug Administration, or FDA in June 2018. The company believes the iStent inject,® measuring 0.23 mm wide and 0.36 mm long, is the smallest medical device ever approved by the FDA. In June 2015, Glaukos completed an initial public offering and our shares are now traded on the New York Stock Exchange under the ticker symbol "GKOS". The company was founded in 1998 and is based in San Clemente, California.
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Details

  • Job Reference: 182894497-2
  • Date Posted: 15 October 2020
  • Recruiter: Contingent Workers
  • Location: San Clemente, California
  • Salary: On Application
  • Sector: Manufacturing Operations
  • Job Type: Permanent