Manufacturing Operations Specialist

3 weeks ago


San Clemente, California, United States Glaukos Corporation Full time
Job Description

Job Title: Lead Manufacturing Technician

Company: Glaukos Corporation

Location: San Clemente, CA

Job Type: Full-time

Job Category: Manufacturing & Operations

Job Summary

We are seeking a highly skilled Lead Manufacturing Technician to join our team at Glaukos Corporation. As a key member of our manufacturing team, you will be responsible for performing various activities related to good documentation practices (GDP), current good manufacturing practices (cGMPs), and quality management system (QMS) medical device good manufacturing practices (GMP) requirements.

Key Responsibilities
  • 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.
  • Kitting operations (measure out components or raw materials)
  • Filing, capping, and crimping operations
  • Packaging and labeling operations
  • Visual inspections
  • Documentation and data input into materials requirement planning (MRP), Batch Records (BRs), and Device History Record (DHR)
  • Prepare components and build device assemblies
  • Request and review documentation (including engineering builds)
  • Support engineering initiatives
  • Real-time review of all executed documentation on the floor
  • Oversee and assign daily production activities
  • Open/close work orders in Maximo and the enterprise resource planning (ERP) system
  • Oversee inventory on a daily basis in the ERP system
  • Ability to address and resolve daily issues on the manufacturing floor
  • Maintain production yield database
Requirements
  • 6+ years of related experience in the medical device, pharmaceutical, and/or biotechnology industries, or a AA with 5+ years of experience or a bachelor's degree with 4+ years of experience
  • Ability to assemble, disassemble, and clean process equipment
  • 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
  • Maintain the operation schedule and allocate resources accordingly
  • Oversee daily production activities
  • Use of Word, Excel and ERP to complete document reviews, training, and inventory
  • Maintain on the floor inventory for accuracy
  • Communicate feedback to engineering on non-standard build requests, validation builds, clinical builds, etc.
What We Offer

Glaukos Corporation offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

We are an equal opportunity employer and welcome applications from diverse candidates.

Please submit your resume and cover letter to apply for this exciting opportunity.



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