Quality Assurance Specialist

6 days ago


Carlsbad, California, United States PSC Biotech Full time
About the Role:
As a seasoned Validation Engineer, you will play a pivotal role in ensuring the highest standards of quality and compliance within our organization. Your primary responsibility will be to lead and execute validation activities for equipment commissioning, qualification, and validation, facility and new product build-outs.

We are seeking an experienced professional with a strong understanding of industry regulations and compliance (cGMP, FDA, etc.). You will collaborate with cross-functional teams to ensure validation activities align with project timelines and quality standards.

Key Responsibilities:
  • Develop, implement, and execute validation protocols (IQ, OQ, PQ) for required equipment and systems.
  • Conduct system and impact assessments to determine validation requirements.
  • Author and review user requirements specifications (URS) and other required validation documentation.
  • Manage change controls to ensure compliance with regulatory requirements.
  • Conduct risk analyses, and implement improvement strategy and corrective and preventative actions.
  • Generate and manage required technical documentation including protocols, reports, etc.


Requirements:
  • Bachelor's degree or higher in a related engineering discipline.
  • Minimum of 5 years of experience in commissioning, qualification, and validation engineering in the pharma/life science industry.
  • Experience with new product build-outs.
  • Strong understanding of industry regulations and compliance (cGMP, FDA, etc.).
  • Proven experience in risk and change control management.
  • Excellent problem-solving skills and attention to detail.
  • Strong communication and interpersonal skills.


Benefits:
  • Competitive salary range: $90,000 - $140,000 annually.
  • Medical, dental, and vision insurance - 100% employer-paid for employees, 50% for dependents.
  • 401(k) matching and education assistance programs.
  • Pet insurance and fitness benefits.


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