Kelly® Science & Clinical is seeking a Quality Systems Scientist for a temp-to-hire position at an early-stage biotech company in South San Francisco, CA . If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Pay Rate : $80 / hour
Overview :
This company is dedicated to revolutionizing human health by developing innovative neuroprotective therapeutics for prevalent, blinding diseases, offering groundbreaking small molecule and gene therapy solutions.
Schedule :
Monday-Friday, Standard Working Hours, hybrid schedule
Responsibilities :
- Help to develop and optimize the company’s Quality Management System (QMS) to ensure compliance with regulatory requirements, internal procedures, and industry standards.
- Support the implementation and oversight of key quality systems, such as Document Control, Supplier Management, Deviations and Complaints.
- Collaborate with cross-functional teams to ensure alignment of quality systems with the company’s overall quality objectives and product development timelines.
- Lead or support investigations into quality-related issues, perform root cause analysis, and ensure timely resolution.
- Develop and deliver training programs on QMS procedures, quality standards, and regulatory requirements for internal staff.
- Review and approve quality documentation, such as SOPs, batch records, and technical reports.
Qualifications :
Bachelor’s degree in Life Sciences, or a related field.5+ years of experience in Quality Systems, Quality Assurance, or a related role within the pharmaceutical or biotechnology industry.Strong understanding of regulatory requirements (FDA, EMA, ICH, GMP) and quality management principles.Experience with Document Control, Complaint and Supplier Management Systems.Ability to conduct audits and investigations into quality issues.