Production Supervisor - Second Shift
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-10-05
Listing for:
Cordis
Full Time
position Listed on 2026-10-05
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
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.
ResponsibilitiesKey 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.
- 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.
- 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.
- 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.
- 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.
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.
- 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.
- 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.
- 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
- 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
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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