Quality Assurance Specialist

4 weeks ago


Gardena, California, United States Spectrum Chemical Mfg. Corp. Full time
Job Title: Quality Assurance Specialist

Spectrum Chemical Mfg. Corp, a leading global supplier of high-quality chemicals, laboratory supplies, and equipment, is seeking a Quality Assurance Specialist to join their team.

Job Summary:

The Quality Assurance Specialist will be responsible for ensuring compliance with applicable regulatory requirements and standards to maintain compliant processes and products' high quality, safety, and purity.

Key Responsibilities:
  • Lead, host, and coordinate virtual or on-site customer audits to present overall quality systems, procedures, and objective evidence.
  • Provide formal audit responses to Customers as required.
  • Support, as assigned, regulatory and certification audits.
  • Maintain an audit-ready book to ensure routinely requested documentation is current and readily available for planned and unannounced audits and inspections.
  • Complete customer quality system questionnaires, surveys, and other inquiries related to the Quality System
Requirements:
  • Bachelor's degree or equivalent experience required.
  • ISO 9001:2015 Lead Auditor or ASQ Certified Quality Auditor certification is a plus, though not required.
  • One (1) to three (3) years of relevant Quality Management System experience in an FDA-regulated and ISO-certified environment is required.
  • Demonstrated working knowledge of ISO 9001:2015, 21 CFR Part 211, and ICH Q7 preferred, knowledge of 21 CFR Part 820, ISO 13485:2016, or other related standards and regulations accepted.
  • Experience working in an e-QMS and ERP system.
  • A good understanding of cGMP and Good Documentation Practices is required.
  • Ability to work closely with internal and external personnel to increase compliance and cooperation while creating opportunities to improve operations and implement effective solutions to reduce errors.
  • Ability to interpret various regulations and standards and communicate requirements to the appropriate individuals.
  • They are highly organized and pay strong attention to detail.
  • Strong Microsoft Office Skills (Word, Excel, PowerPoint).
  • Strong written and oral communication skills.
Travel and Schedule:

Domestic and international travel may be required to conduct audits. Varied shifts depending on the schedule of inspections and audits. It may require additional hours to support business needs.



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