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Production Supervisor - Second Shift

Job in Irvine, Orange County, California, 92713, USA
Listing for: Cordis
Full Time position
Listed on 2026-10-05
Job specializations:
  • Quality Assurance - QA/QC
    Regulatory Compliance Specialist, Quality Engineering
Salary/Wage Range or Industry Benchmark: 78650 - 105600 USD Yearly USD 78650.00 105600.00 YEAR
Job Description & How to Apply Below

Overview

Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs.

Responsibilities

Key Responsibilities Team Management
  • Supervise, train, and mentor laboratory technicians and scientists.
  • Assign work, set priorities, and monitor performance against timelines and quality expectations.
  • Conduct performance reviews and support development plans.
  • Promote a culture of safety, accountability, and continuous improvement.
Laboratory Operations
  • Supervise day-to-day laboratory activities, including formulation preparation, and control.
  • Ensure adherence to approved procedures, protocols, and work instructions.
  • Oversee use and maintenance of laboratory equipment (e.g., mixers, reactors, particle sizers, microscopes, refrigerators, etc.).
  • Support method development, optimization, and transfer to manufacturing or pilot scale.
  • Review laboratory data for accuracy, completeness, and compliance.
Quality, Compliance & Data Integrity
  • Ensure compliance with GMP, ISO 13485, and internal quality system requirements.
  • Enforce proper documentation practices, including batch records, lab notebooks, and electronic data systems.
  • Participate in investigations, deviations, CAPAs, and change controls related to lab processes.
  • Support internal and external audits and regulatory inspections.
Safety & EHS
  • Ensure compliance with laboratory safety, chemical handling, and waste disposal requirements.
  • Conduct or support safety training and risk assessments.
  • Investigate and report safety incidents or near misses.
Cross-Functional Collaboration
  • Collaborate with R&D, Manufacturing, Quality, Engineering, and Regulatory teams.
  • Support scale-up activities and technology transfers.
    • Provide technical input to project teams and leadership.
Qualifications

Required Qualifications
  • Bachelor’s degree in Chemistry, Chemical Engineering, Materials Science, Biomedical Engineering, or related field or the equivalent combination of education and experience.
  • Minimum 4 years of laboratory experience.
  • Experience working under GMP/GLP or ISO-regulated systems.
Preferred Qualifications
  • 2+ years of supervisory or team-lead experience in a regulated laboratory environment.
  • Experience in medical device or pharmaceutical manufacturing.
  • ASQ or related analytical chemistry certification.
Key Competencies
  • Familiarity with analytical tools (e.g., particle size analysis, microscopy, and efficiency testing).
  • Understanding process development and scale-up principles.
  • Proficient in documentation and electronic data systems.
  • Strong people-management and coaching skills.
  • Excellent communication and organizational abilities.
  • Detail-oriented with strong problem-solving skills.
  • Ability to manage multiple priorities in a fast-paced environment.
Key Performance Indicators (KPIs)
  • On-time completion of laboratory activities and projects
  • Right-first-time documentation and data integrity compliance
  • Reduction in deviations and rework
  • Team training completion and competency levels
  • Audit readiness and inspection outcomes
Working Conditions
  • Laboratory environment with exposure to chemicals and particulate materials
  • Requires use of PPE and adherence to safety protocols
  • May require occasional extended hours to support projects or investigations
Pay / Compensation

The expected pre-tax pay rate for this position is $78,650 - $105,600 per year. Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The…

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