Process Improvement Manager

3 weeks ago


San Jose, California, United States PSC Biotech Full time

PSC Biotech Overview

PSC Biotech is a global leader in providing life sciences services, ensuring the highest standards in healthcare product development, manufacturing, and distribution. Our company values include a commitment to quality, compliance, and customer satisfaction.

Job Title: QA Auditor

Job Summary: We are seeking an experienced QA Auditor to support the transition of a new CMO facility. This is a temporary role, focusing on SOP audits, gap analyses, and staff training.

Key Responsibilities:

  • Conducting thorough GAP analysis and auditing of standard operating procedures.
  • Providing quality recommendations for GxP processes and environmental monitoring procedures.
  • Delivering high-level GMP training programs for staff members.
  • Establishing and maintaining GMP processes that meet industry regulations and compliance standards.
  • Providing technical guidance and support for program changes and execution.

Requirements:

  • Bachelor's degree in a relevant scientific discipline.
  • 5+ years of quality assurance experience in the pharmaceutical and/or biotech industry.
  • Advanced understanding of cGxP regulations, EU regulations, and industry compliance.
  • Experience in quality auditing and GAP analysis.
  • Excellent attention to detail with proven success in reviewing and editing standard operating procedures.
  • Ability to effectively train team members and foster a collaborative team environment.
  • Analytical and able to provide technical support and guidance in decision-making and program improvement.

Estimated Salary: $45 - $60 per hour.



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