Quality Specialist III

Job Title: Quality Specialist III
Job Location: 1 DNA Way, South San Francisco, CA 94080 (Hybrid)
Duration: 6 months contract with possibility for extension
Payrate: $27.10 $57.17 per hr. on W2
Work Model: Hybrid - three days on site, two days remote

Job Description:
We are seeking a Quality Specialist III to support clinical trial product delivery and ensure compliance with cGMP regulations. This role focuses on providing quality oversight for CDMO/CRO operations across multiple technical platforms and ensuring that high-quality, compliant products reach patients worldwide. The position requires strong cross-functional collaboration, process excellence, and a continuous improvement mindset.

Responsibilities:

• Provide quality and GMP compliance oversight of CDMO/CRO operations for the delivery of products to clinical trials, including bulk drug substance (API) and bulk drug product across multiple technical platforms.
• Ensure cGMP compliance and execute activities in support of disposition of clinical API and Drug Product manufactured at CDMOs, including but not limited to:
• Approval of master process and testing documentation
• Batch record review
• Leading and approving complex investigations
• Assessing and approving changes
• Ensure project milestones and expectations such as timely closure of activities are met.
• Execute activities in support of global clinical trials, such as maintaining the Product Specification File.
• Oversee and execute all required quality activities during the lifecycle of a CDMO/CRO, including but not limited to:
• Negotiation and maintenance of Quality Agreements
• Monitoring cGMP compliance, identifying, and mitigating quality risks
• Supporting audits, ensuring audit responsiveness, and CAPA implementation

Qualifications and Skills

• B.A. or B.S. degree in life sciences
• Minimum of 6 years experience in the pharmaceutical industry.
• Minimum of 2 years experience in a GMP Quality Assurance role.
• Must have experience making GMP release / disposition decisions and associated approval of master process and testing documentation, batch record review, resolution and quality approval of investigations, assessment of changes for clinical API and/or Drug Product, preferably synthetic molecules. Experience with SAP and Veeva is a plus. Experience with CDMO desired.
• Sound knowledge of cGMP, ISO standards and international regulations for pharmaceuticals. Ability to interpret quality standards as they relate to CDMO/CRO, especially application of phase appropriate cGMP during product development for a variety of platforms, such as large molecule, synthetic molecule, conjugates, and oligonucleotides.
• Demonstrated ability to apply cGMP concepts and requirements to evaluate batch disposition using sound judgment and decision making.
• Strong problem solving skills using critical thinking, identifying risk based resolutions
• Excellent verbal and written communication skills. Fluency in oral and written English is a must.
• Strong interpersonal skills, diplomacy, and negotiation skills to influence and accomplish business objectives.

#TMN