Process Improvement Manager
3 weeks ago
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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