Quality Engineer - Validation & Documentation

PSC Biotech® Corporation

Pomona (CA)

On-site

USD 110,000 - 120,000

Full time

2 days ago
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Benefits offered by this job

Medical, Dental, Vision - company pays
401(k) and matching
PTO, Sick Time, Paid Holidays
Education Assistance
Pet Insurance
Anytime Fitness discount
Financial Perks and Discounts

Job summary

PSC Biotech Corporation is seeking a Quality Engineer to provide QA oversight of validation documentation and ensure GMP compliance. The role focuses on review, approval, and management of validation records to maintain accuracy and inspection readiness.

Ideal candidates will have 5+ years in QA/Validation within regulated environments, with knowledge of IQ/OQ/PQ, risk assessments, and change controls, and strong communication skills. This on-site role offers comprehensive benefits.

Qualifications

  • Experience in QA and validation documentation within GMP environments.
  • Familiarity with IQ/OQ/PQ protocols and change controls.
  • Strong attention to detail and written communication.

Responsibilities

  • Perform QA review and approval of validation documentation.
  • Ensure documents meet GMP and regulatory expectations.
  • Review validation records for accuracy, traceability, and adequacy.
  • Collaborate with Validation, Engineering, Manufacturing and Quality teams.
  • Support internal audits and regulatory inspections as needed.
  • Assist with continuous improvement of validation docs and quality systems.

Skills

QA experience
Validation docs
IQ/OQ/PQ
Regulatory compliance
Communication skills
Independent work

Education

Bachelor's degree in Engineering/Life Sciences/QA

Tools

Document management systems

Job description

PSC Biotech Corporation is seeking a Quality Engineer to provide QA oversight of validation documentation and ensure GMP compliance. The role focuses on review, approval, and management of validation records to maintain accuracy and inspection readiness.

Ideal candidates will have 5+ years in QA/Validation within regulated environments, with knowledge of IQ/OQ/PQ, risk assessments, and change controls, and strong communication skills. This on-site role offers comprehensive benefits.

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