Overview
Quality System Specialist Jobs in San Diego, California, USA at Barrington James
Recruitment Consultant – Quality – US & Canada
We are seeking an experienced Quality/CMC Specialist to support our quality team in implementing a fit-for-purpose quality system for mRNA starting materials. The ideal candidate will ensure compliance with necessary validation systems, supplier qualifications, and ISO certifications while balancing the need for efficiency and regulatory flexibility. This role focuses on raw materials integral to mRNA drug substance production without requiring full GMP compliance.
Key Responsibilities:
Provide hands-on quality/CMC expertise for mRNA starting materials used in drug substance manufacturing.
Oversee quality processes for raw materials, ensuring appropriate validation and supplier qualification.
Implement and maintain a fit-for-purpose quality system tailored to mRNA production, distinct from full GMP drug product systems.
Ensure compliance with required quality standards and certifications, supporting audits as needed.
Guide internal teams on best practices for mRNA material quality systems, ensuring efficiency without overburdening compliance requirements.
Qualifications & Experience:
Proven experience in mRNA quality systems, particularly for raw materials used in drug substance production.
Background working with industry leaders.
Strong understanding of quality requirements for mRNA product types, including raw materials, supplier qualifications, and validation systems.
Experience managing quality systems and compliance processes for mRNA-related starting materials.
Contract:
6 Months
Sponsorship Unavailable
Seniority level: Associate
Employment type: Contract
Job function:Quality Assurance
Industries: Biotechnology Research and Pharmaceutical Manufacturing
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Title: Quality System Specialist
Company: Barrington James
Location: San Diego, California, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Engineering, Quality Technician/ Inspector, QA Specialist / Manager)
