Quality Systems SpecialistKelly Science, Engineering, Technology & Telecom • South San Francisco, CA, US
Quality Systems Specialist
Kelly Science, Engineering, Technology & Telecom • South San Francisco, CA, US
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job_description.job_card.job_descriptionBachelor'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. Associate Full-time Quality Assurance and Science
Overview
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
Pay Rate : $80 / hour
Schedule : Temp-to-hire
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
Seniority level
Employment type
Job function
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