Quality Management Leader (ISO 9001 & GMP)

Aurorium

Pasadena (TX)

On-site

USD 110,000 - 160,000

Full time

14 days+

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Benefits offered by this job

Medical insurance
Dental insurance
Vision insurance
401(k)
Paid time off
Paid holidays
Life insurance

Job summary

Aurorium in Pasadena, TX, is seeking a Quality Manager to lead QA and QC efforts, build and maintain the ISO 9001 quality system, and ensure products meet customer and regulatory requirements.

You will drive investigations, coordinate audits, and mentor the QA team while partnering with Regulatory Affairs to ensure continuous improvement and safe, compliant operations across the site.

Qualifications

  • BS or higher in Chemistry or Engineering; MS preferred.
  • Internal auditor training and ISO 9001 knowledge.
  • CGMP familiarity; ASQ CQE/CQA preferred.

Responsibilities

  • Oversee development and maintenance of on-site Quality Management System.
  • Approve all plant procedures affecting product quality.
  • Lead ISO 9001 and GMP compliance activities.
  • Coordinate regulatory affairs and product registrations.
  • Lead investigations of customer complaints and quality issues.
  • Manage quality documentation and training programs.

Skills

Quality management
Problem solving
Regulatory compliance
Auditing
Team leadership

Education

BS in Chemistry or Engineering
MS preferred

Tools

MS Office
SAP

Job description

Aurorium in Pasadena, TX, is seeking a Quality Manager to lead QA and QC efforts, build and maintain the ISO 9001 quality system, and ensure products meet customer and regulatory requirements.

You will drive investigations, coordinate audits, and mentor the QA team while partnering with Regulatory Affairs to ensure continuous improvement and safe, compliant operations across the site.

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